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From the Department of Anesthesia and Intensive Care, St. Olav's Hospital, University Hospital of Trondheim, Trondheim, Norway.
Address correspondence to: Dr. Sigurd Fasting, Department of Anesthesia and Intensive Care, St. Olav's Hospital, University Hospital of Trondheim, N-7006 Trondheim, Norway. Phone: +47-73868108; Fax: +47-73868117; E-mail: sigurd.fasting{at}medisin.ntnu.no
| Abstract |
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Methods: We prospectively recorded anesthesia-related information from all anesthetics for five years. The data included intraoperative problems, which were graded into four levels, according to severity. We analyzed only the serious nonfatal problems, which were sorted according to clinical presentation, and also according to which factor was most important in the development of the problem. We assessed any untoward consequences for the patient, and whether the problems could have been prevented.
Results: Serious problems were recorded in 315 cases out of 83,844 (0.4%). Anesthesia was considered the major contributing factor in 111 cases. Difficult intubation, difficult emergence from general anesthesia, allergic reactions, arrhythmia and hypotension were the dominating problems. Twenty-six anesthesia related problems resulted in changes in level of postoperative care, and one patient later died in the intensive care unit after anaphylactic shock. Eighty-two problems could have been prevented by simple strategies.
Conclusion: Analysis of serious nonfatal problems during anesthesia may contribute to improved preventive strategies. Data from a routine-based system are suitable for this type of analysis. Intubation, emergence, arrhythmia, hypotension and anaphylaxis cause most serious problems, and should be the object of preventive strategies.
| Introduction |
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Anesthetic complications, such as mortality and major morbidity, do not occur spontaneously but are the outcome of an evolutionary process. Through multiple interactions, a simple incident evolves to a serious one that may further evolve to an accident.4 Because of recovery processes such as error detection and treatment, minor incidents are more common than serious incidents, which in turn occur more frequently than accidents. The rarity of mortality and major anesthetic morbidity makes it difficult to study the etiology of adverse outcomes and to develop preventive strategies.1,57 However, the greater frequency of incidents or near misses affords opportunities for accident prevention, as well demonstrated in aviation, nuclear power and other high-risk industries.13
We report our analysis of serious problems during anesthesia, almost all of which would be classified as critical incidents, in that most did not progress to a serious outcome. The data are derived from a simple routine based system of problem reporting, recorded in a clinical database.8 Our aim was to analyze the pattern and causes of serious problems, and then to use this information to improve preventive strategies.
| Methods |
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One of the data fields, intraoperative problems (Appendix), includes a list of 22 common anesthesiological problems, as well as a field for severity (grade 14). The anesthesiologist writes a short description of any problem occurring during the anesthetic, and marks the problem checkbox on the chart accordingly. If the case was uneventful', this also must be indicated in a checkbox. Other data fields on the chart relate to the patient, the operation, type of anesthetic, and timing of events.
An intraoperative problem is defined as an event that requires one or more measures either to prevent further complications, or to treat a situation that is currently or potentially serious, and which does not routinely occur during the conduct of anesthesia. The problems are graded according to severity, using a scale from one to four. Grade 1 is a trivial problem, easily dealt with and not affecting the patient's condition. Grade 2 represents moderate difficulty, with some effect on the patient, but of a low severity. Grade 3 is a serious situation which is either very difficult to manage, or which causes a serious deterioration in the patient's state, and which may or may not have postoperative consequences. Grade 4 problems imply a fatal outcome during anesthesia and surgery.
All cases of general anesthesia, regional anesthesia, and sedation for surgical procedures from the years 19962000 were selected from the departmental database, and included in the study cardiac surgery was excluded (n = 3,405). Cases with recorded problem situations of grade 3 and grade 4 severity were identified and analyzed more closely. The copies of the corresponding anesthetic charts were retrieved from departmental archives. The authors performed the analysis of the cases, using predefined criteria for severity or clinical judgement, based on the patient's medical history, the documentation on the anesthetic chart, and the information in the database.
Firstly, the problems were sorted according to their clinical presentation: hypotension, intubation problems, arrhythmia, allergy, difficult emergence and other. Secondly, we assigned the problems to one of three categories, according to which major factor was considered the most important in the progression of the problem. These categories were Anesthesia, The patient's medical condition, and Surgery. Thirdly, we then determined any contributing factors, using the same three categories. Fourthly, we further analyzed the problems where Anesthesia was the major factor, or a contributing factor in cases where the patient's medical condition was the most important, to see if there were any untoward consequences, such as postponement of surgery, or the need for an increased level of postoperative care. Lastly, we evaluated if these problems could have been prevented - and which preventive strategies could have been used.
A chi square test was performed to compare groups, and P < 0.05 was considered statistically significant.
| Results |
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Hypotension
Serious hypotension occurred in 124 patients (Table II
). Anesthesia was the major factor in only 13 cases, in contrast to surgery (n = 18; bleeding) and the patient's medical condition (n = 93; trauma, ruptured aortic aneurysm, septic shock, heart failure). Anesthesia was a contributing factor in an additional 27 cases, where the major factor was the patient's condition. Details of the 40 cases where anesthesia was a major or contributing factor are presented in Table III
.
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Possible preventive measures included improved preoperative evaluation and stabilization of seriously ill patients, and better choice of the induction doses.
Problems with intubation
Eighty-two serious intubation problems were recorded in 40,423 general anesthetics with tracheal intubation (0.2%). Anesthesia was considered the major factor in 25 cases, and a contributing factor in 41 cases, when the main contribution was the patient's medical (or anatomical) condition (Table II
).
Details of the 66 intubation problems related to anesthesia are shown in Table IV
. Twenty-nine were considered preventable. Failed recognition of anatomical stigmas for difficult intubation, and choice of inappropriate primary intubation technique in patients where intubation was known or suspected to be difficult, were the most common causes.
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There was no difference in the need to modify postoperative management between those with anticipated problems (6/24) compared to those with unexpected problems (17/42). No patient suffered any lasting morbidity.
Possible preventive measures included better routines for preoperatively predicting difficult intubation, and algorithms for choosing the optimal primary intubation technique in cases with anticipated difficulties.
Arrhythmias
There were 27 serious arrhythmias. Anesthesia was the major factor in 14, surgery in one, and the patient's medical condition in 12. Three of the latter had anesthesia as a contributory factor (Table II
). Details of the anesthesia related arrhythmias are presented in Table V
. The largest group comprised extreme bradycardia or asystole (n = 14). Eleven occurred during spinal anesthesia, four developing more than 60 min after onset of blockade. Five patients received chest compressions in addition to medication. Five patients with arrhythmia needed ICU admission; mainly because of their poor medical condition. Five of the problems were considered preventable (Table V
).
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Problems during emergence from general anesthesia
We recorded 27 serious problems during emergence; only two were unrelated to anesthesia; they suffered postoperative bleeding during emergence, one post-tonsillectomy, and one postcraniotomy. All the anesthesia-related cases had undergone tracheal intubation, and suffered severe airway or oxygenation problems during emergence. Eight of the 23 patients where anesthesia was the major factor, and the two patients where the major factor was surgery, needed unplanned admission to the ICU. No serious problems were recorded during emergence from mask anesthesia or laryngeal mask anesthesia.
All anesthesia related problems were considered preventable. Fourteen were related to misjudgment of residual drug effect, usually opioids or muscle relaxants. In three cases, extubation should not have been attempted because of poor general condition or lung function. In five cases, the patient had severe laryngo- or bronchospasm after extubation, and one patient aspirated. The most important possible preventive measures were a more critical application of extubation criteria, including possible residual effect of drugs, and consideration of delayed extubation in the ICU.
Allergy problems
Fourteen patients had serious allergic reactions. Thirteen had severe anaphylactoid or anaphylactic reactions during approximately 40,000 cases of general anesthetics with neuromuscular blocking drugs (1:3,000). Four had to be admitted to the ICU. One patient developed anaphylactic shock with treatment-resistant cardiac arrest, and later died in the ICU. Three reactions were associated with the use of succinylcholine, and ten with non-depolarizing drugs.
One patient, undergoing gastroscopy with sedation, developed angioedema in the face and throat, requiring ICU admission. The patient was on angiotensin converting enzyme-inhibitors, which are known to be associated with angioedema.9 Two patients had a history of drug allergy, although not to any anesthetic drugs. None of the allergy problems were considered preventable; prevention is difficult, but early diagnosis and prompt and aggressive treatment may prevent morbidity.
Other problems
Pulmonary aspiration occurred in five patients who were having general anesthesia. Four had serious underlying medical conditions predisposing to gastric retention, but rapid sequence induction was not performed. Two were admitted to ICU after aspiration. All cases of aspiration were considered preventable, and anesthesia was considered a major factor.
Serious laryngospasm occurred in four patients, two of whom were children. All had airway and oxygenation problems. All were considered preventable with better anesthetic techniques, but the problems did not affect postoperative care.
Three patients received hypoxic gas mixtures when the intention was to give 100% oxygen, and in one patient a syringe containing succinylcholine was mistaken for saline and used to flush an iv line while the patient was still awake. All these problems were preventable, and did not influence the patient's postoperative course.
Other less common problems are presented in Table II
. All incidents in which anesthesia was a major factor, were considered preventable, other problems were not. Only one patient, who suffered a pneumothorax, needed admission to ICU.
Problems of grade 4 - intraoperative death
Forty-two patients died intraoperatively, all were ASA IV or V, except three with uncontrollable surgical bleeding. The most common diagnoses were ruptured aortic aneurism (n = 21), multitrauma (n = 8), and septic shock (n = 5). There were no anesthesia related deaths.
Clinical consequences
Twenty-seven percent (85/315) of all grade 3 problems resulted in a change in the patient's expected postoperative course. Sixty-one had an unplanned ICU admission, three underwent tracheotomy, and in 21 the operation was postponed because of intubation difficulties. One patient later died in the ICU after an anaphylactic reaction.
Among the problems where anesthesia was considered the major factor, 23% (26/111) resulted in a change of plans. Eighteen patients had to be admitted to ICU, one had a tracheotomy, and in seven, surgery was postponed because of intubation difficulties.
Among patients with preventable anesthesia problems 24% (20/82) had a change in postoperative course. Thirteen had to be admitted to ICU, one had a tracheotomy, and in six cases, surgery was postponed because of intubation difficulties.
| Discussion |
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Methodology
Anesthetic mortality and serious morbidity are becoming exceedingly rare, and therefore their analysis is of limited value for quality improvement efforts.1,57 This is also the case in our study, in which all the intraoperative deaths were caused by life-threatening medical conditions or surgical factors. Study of the near miss - the serious nonfatal anesthetic problem - is therefore a more valuable starting point for preventive strategies,5,6,10,11 a philosophy used in aviation and other complex non-medical industries for years.1,3
On the other hand, it has been argued that intraoperative incidents are surrogate outcomes for real' postoperative morbidity.12 Our study focused on serious nonfatal intraoperative problems, which have an undeniable potential for serious morbidity and mortality. Twenty-three percent of these problems affected the patient's postoperative course, either as an unplanned admission to ICU, or postponement of surgery.
Since all patients receiving an anesthetic were included in the study, and critical incidents were recorded systematically for all anesthetics, important events were unlikely to be missed. This contrasts to studies where information is collected from selected samples of patients. However, underreporting may still occur, possible causes being the added workload of completing forms, the belief that reporting is of limited value, and fear of consequences of reporting.1316 We believe that the reporting compliance in our study was good, since our system is designed to add minimal workload. All recording is done directly on the anesthetic chart, and no additional paperwork is needed. The data is used actively in our department, for morbidity meetings and quality improvement projects. Further, we have created a nonpunitive reporting culture, where it is safe to admit and report problems. Problems are met with an attitude of learn and prevent rather than blame and hide,17 and thus we believe that the reported incidence is representative for our practice.
Frequency and pattern of serious problems
Intubation, difficult emergence, arrhythmia, anaphylaxis and hypotension were the commonest serious problems. Four studies, all representing mandatory reporting, are partially comparable to ours.10,1820 These report both the occurrence and severity of incidents, but all have evaluated incidents in the perioperative period, i.e., in the operating room and the recovery room together.
Cooper and coworkers reported incidents in the operating room or the recovery room as recovery room impact events (RRIE).10 A RRIE was an event that needed intervention, was pertinent to recovery room care, and did or could cause mortality, or at least moderate morbidity. A RRIE occurred in the operating room in 13.8% of the anesthetics, but the severity of these events was not stated. The four most frequent intraoperative problems in this study were hypotension, arrhythmia, hypertension and difficult intubation.
Three studies have been published from a large German Quality Assurance project.1820 Sixty-three types of incidents were defined, and five levels of severity according to their impact on postoperative care. Serious problems (severity class 45) occurred in 1.2% in 18,350 cases,18 0.9% in 26,907 cases,19 and 1.0% in 96,000 cases.20 The frequency of all problems was 23.2%, 27.9% and 22% respectively.1820 The most common serious problems were respiratory, arrhythmia, and hypotension.
Again, comparison with our study, is difficult, as these studies also included recovery room events. We did not use the recovery room impact as a criterion for severity, as it may not always be adequate. For example most airway problems are treated without sequel, but still have the potential for catastrophic outcome.21 It is important to evaluate the potential for disaster as well as the actual morbidity.
Hypotension
Hypotension is the most common serious problem in our study, as elsewhere,10,1820 but its exact definition is difficult. We defined it as a reduction to < 70% of baseline for more than five minutes, or any reduction to < 50%.
Serious hypotension was related principally to serious medical conditions or surgical bleeding, rather than anesthesia. The most important preventive measures were thus better preoperative evaluation, stabilization, and better adjustment of induction drug dosage.
Fourteen cases of serious hypotension were caused by circulatory collapse during central neuraxial blockade. Seven of these were caused by inadequate correction of hypovolemia before blockade, a recognized risk factor.22
Problems with intubation
Airway problems are an important cause of death and serious morbidity;2325 our incidence was 0.2%. In a study by Rose and Cohen, 0.4% of cases required more than three attempts at laryngoscopy, and 0.3% could not be intubated by standard laryngoscopic techniques.26 Again, the frequency of problems will vary according to the definition used.27
Unexpected intubation difficulties are more likely to produce hypoxemia and, therefore, probably have a greater accident potential than expected difficulties. Different methods for preoperative airway evaluation have been tested with different predictive values.26,2830 We evaluated mouth opening and neck movement, but have not included strict assessment of thyromental distance or Mallampati score in our routine evaluation. Nearly half of our patients with unexpected intubation problems had anatomical stigma predicting intubation difficulties when re-evaluated after the incident. Better routines for preoperative evaluation may help reduce the risk.28,31
Fortunately, no intubation problem resulted in major morbidity or mortality. We discontinued attempts at intubation in one-third of the cases, and two patients had a tracheotomy. Early discontinuation of intubation attempts is advised,31 and may have prevented serious morbidity in our study.
Difficult emergence from general anesthesia
Difficult emergence from general anesthesia was associated with serious problems in our study, but is seldom mentioned explicitly elsewhere. The main problems were related to airway and hypoventilation, and the emergence problems may have been categorized as airway problems in other studies.
The causes were either misjudgment of residual drug effect or of the patient's respiratory status before extubation. We do not routinely monitor neuromuscular blockade, and there is pressure to extubate in the operating room, rather than in the postoperative care unit, where capacity is limited. Possibly, delayed extubation should be considered more often; our routines need to be re-evaluated.
Arrhythmia
Bradycardia and asystole were the most common serious arrhythmias. Their low frequency probably reflects prompt diagnosis and treatment of bradycardia and hypotension during central neuraxial blockade. Prompt intervention is necessary to avoid life-threatening circulatory collapse.22,32
One ventricular arrhythmia was caused by accidental iv injection of local anesthetic, and is a reminder that full resuscitation facilities are needed when performing regional anesthesia.
Allergy-anaphylaxis
The frequency of serious allergic reactions was 1:6,000 in our study, while in the German studies the frequency ranged from 1:4,500 to 1:6,400.1820 In a French study by Laxenaire and coworkers the frequency of anaphylactic and anaphylactoid reactions during anesthesia was 1:4,850.33 In the studies by Laxenaire and coworkers, anaphylactic shock had a 1% rate of mortality or severe neurological sequelae.33,34 The only patient to die in our study was a man, ASA class II, in whom hypotension and tachycardia dominated the symptoms and delayed the diagnosis of anaphylaxis. Circulatory collapse is the sole predominant symptom in about 10% of anaphylactic reactions associated with anesthesia,34 and it is important to bear this in mind when a patient develops severe hypotension after drug injection.
Other problems
We had no cases of classic aspiration of gastric contents, i.e., patients with a suspected full stomach or peritonitis who aspirated during induction. We follow the Norwegian National Fasting Guidelines,35 which recommend preoperative gastric emptying only before induction of general anesthesia where ileus is suspected. Earlier, we had shown these routines to be safe.36 However, it is important to evaluate the risk for pulmonary aspiration also in patients outside the classic full stomach group, as gastric retention can be secondary to other serious conditions. The frequency of serious aspiration is very low in our study and similar to that in our previous study.36
Quality issues
To compare problem frequencies with other studies is difficult, because of differences in definitions and recording systems.10,19,20,37 Cohen and coworkers found that, even with the same recording system, comparisons between hospitals were difficult.6 However, for departmental use, the frequency and pattern of problems may be useful indicators of quality. A routine based system will also track changes in problem patterns and occurrence, allowing continuous adjustment of preventive and educational efforts.
Nevertheless, the serious problems reported within one institution also represent a lesson for all'. The patterns and possible preventive strategies are transferable to other institutions, and may be suitable for accumulation in a central database, as in the Australian AIMS project38 and in parallel to systems for reporting near misses in aviation.13
| Conclusion |
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| Footnotes |
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Revision received March 15, 2002. Accepted for publication January 8, 2002.
| References |
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Helmreich RL. On error management: lessons from aviation. BMJ 2000; 320: 7815.
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Cohen MM, Duncan PG, Pope WDB, et al. The Canadian four-centre study of anaesthetic outcomes: II. Can outcomes be used to assess the quality of anaesthesia care? Can J Anaesth 1992; 39: 4309.
7 Lee A, Lum ME. Measuring anaesthetic outcomes. Anaesth Intensive Care 1996; 24: 68593.[Medline]
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9 Vleeming W, van Amsterdam JGC, Stricker BHC, de Wildt DJ. ACE inhibitorinduced angioedema. Incidence, prevention and management. Drug Saf 1998; 18: 17188.[Medline]
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11 Spencer FC. Human error in hospitals and industrial accidents: current concepts. J Am Coll Surg 2000; 191: 4108.[Medline]
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17
Cohen MR. Why error reporting systems should be voluntary. BMJ 2000; 320: 7289.
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19 Schwilk B, Muche R, Treiber H, Brinkmann A, Georgieff M, Bothner U. A cross-validated multifactorial index of perioperative risks in adults undergoing anaesthesia for non-cardiac surgery. Analysis of perioperative events in 26907 anaesthetic procedures. J Clin Monit Comput 1998; 14: 28394.[Medline]
20
Bothner U, Georgieff M, Schwilk B. Building a large-scale perioperative anaesthesia outcome-tracking database: methodology, implementation, and experiences from one provider within the German quality project. Br J Anaesth 2000; 85: 27180.
21 Sigurdsson GH, McAteer E. Morbidity and mortality associated with anaesthesia. Acta Anaesthesiol Scand 1996; 40: 105763.[Medline]
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23 Runciman WB. Risk assessment in the formulation of anaesthesia safety standards. Eur J Anaesthesiol Suppl 1993; 10(Suppl. 7): 2632.
24 Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia - a prospective survey in France. Can Anaesth Soc J 1986; 33: 33644.[Medline]
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26
Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth 1994; 41: 37283.
27
Rose DK, Cohen MM. The incidence of air-way problems depends on the definition used. Can J Anaesth 1996; 43: 304.
28 Randell T. Prediction of difficult intubation. Acta Anaesthesiol Scand 1996; 40: 101623.[Medline]
29 El-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg 1996; 82: 1197204.[Abstract]
30
Arné J, Descoins P, Fusciardi J, et al. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth 1998; 80: 1406.
31
Crosby ET, Cooper RM, Douglas MJ, et al. The unanticipated difficult airway with recommendations for management. Can J Anaesth 1998; 45: 75776.
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33 Laxenaire MC et le Groupe d'etudes des réactions anaphylactoïdes peranesthésiques. Épidémiologie des réactions anaphylactoïdes peranesthésiques. Quatrième enquête multicentrique (juillet 1994-décembre 1996). Ann Fr Anesth Reanim 1999; 18: 796809.[Medline]
34
Laxenaire MC, Mertes PM, and Groupe d'Etudes des Réactions Anaphylactoïdes Peranesthésiques. Anaphylaxis during anaesthesia. Results of a two-year survey in France. Br J Anaesth 2001; 87: 54958.
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36 Mellin Olsen J, Fasting S, Gisvold SE. Routine preoperative gastric emptying is seldom indicated. A study of 85 594 anaesthetics with special focus on aspiration pneumonia. Acta Anaesthesiol Scand 1996; 40: 11848.[Medline]
37 Cohen MM, Duncan PG, Pope WDB, Wolkenstein C. A survey of 112,000 anaesthetics at one teaching hospital (1975-83). Can Anaesth Soc J 1986; 33: 2231.[Medline]
38 Webb RK, Currie M, Morgan CA, et al. The Australian Incident Monitoring Study: an analysis of 2000 incident reports. Anaesth Intensive Care 1993; 21: 5208.[Medline]
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