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From the Département danesthésie-réanimation, Centre hospitalier affilié universitaire de Québec, Université Laval, Québec, Québec, Canada.
Address correspondence to: Dr. Claude A. Trépanier, Département danesthésie-réanimation, Hôpital de lEnfant-Jésus du CHA, 1401, 18e rue, Québec, Québec G1J 1Z4, Canada. Phone: 418-649-5807; Fax: 418-649-5918; E-mail: delalaitue{at}videotron.ca
| Abstract |
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Methods: Since 1993, in the Quebec City Health Region, the basic life support treatment algorithm for emergency medical technicians has included the use of a Combitube as the primary airway device for management of all patients presenting with cardiac or respiratory arrest. The database of the emergency coordination services was searched for the period between 1993 and 2003 (2,981 patients). Only those patients who survived at least 12 hr were included. Medical records of these patients were reviewed to identify complications related to the use of the Combitube.
Results: Two-hundred-eighty (280) patients were identified. Fifty-eight (58) patients (20.7%, confidence interval (CI)95% = 16.0%25.4%) presented 69 complications: aspiration pneumonitis (n = 31), pulmonary aspiration (n = 16), pneumothorax (n = 6), upper airway bleeding (n = 4), esophageal laceration (n = 3), sc emphysema (n = 2), esophageal perforation and mediastinitis (n = 2), tongue edema (n = 2), vocal cord injury (n = 1), tracheal injury (n = 1), and pneumomediastinum (n = 1). Thirteen of these complications (12 patients, 4.3%, CI95% = 2.0%6.3%) were judged as most likely resulting from trauma associated with insertion of the Combitube.
Conclusion: The use of the Combitube in the pre-hospital setting is associated with a notable incidence of serious complications.
| Introduction |
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Many serious complications, including but not limited to aspiration pneumonitis, pneumothorax, pneumomediastinum, airway injuries, esophageal lacerations and perforations have been reported with the Combitube.6,10,11 However, limited data on the incidence and severity of these complications are available, in spite of its widespread acceptance in the pre-hospital setting.3 The primary objective of this retrospective chart review was to determine the incidence of the complications associated to the Combitube in the pre-hospital setting. The secondary objective was to evaluate the nature and severity of these complications.
| Methods |
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Data for all patients managed by EMTs according to the preceding algorithm are entered into the database of the emergency coordination services of the Quebec City Health Region. With the permission of the Director of pre-hospital care of the Quebec City Health Agency, this database was searched for the period between August 1994 and January 2003, and patients alive upon arrival at the emergency room were identified. Among those, patients who survived at least 12 hr following admission to the emergency room were included in the study. Hospital records of those patients were reviewed by one of the investigators (M.C.V.), after obtaining authorization from the medical directors of each of the 14 hospitals of the Quebec City Health Region.
Data collected from the emergency coordination services database included: age, gender, indication for the Combitube, size of the Combitube, number of insertion attempts, successful or failed attempt, presence of vomiting prior to or after insertion, presumed position of the Combitube (tracheal vs esophageal), and air volume injected into each balloon. Data collected from the medical records included: weight and height of the patient, death or survival, evaluation of the Combitube position by the emergency room medical staff, need for secondary endotracheal intubation, and its timing. Complications potentially related to the Combitube were searched by reviewing the medical and nursing notes, radiographic examination reports, laboratory tests and autopsy reports when available. Complications sought were defined as: pulmonary aspiration (presence of gastric fluid in the respiratory tract), aspiration pneumonia (pneumonia requiring antibiotics within 48 hr of admission), pneumothorax and pneumomediastinum (confirmed by chest radiography), esophageal and tracheal lacerations (confirmed by endoscopic examination), esophageal perforation and mediastinitis (confirmed by endoscopic examination or leakage during contrast medium swallowing), sc emphysema , upper airway bleeding, and tongue edema. When a complication could be related either to the insertion of a Combitube or to subsequent endotracheal intubation, the case was reviewed and discussed by three investigators and included in the analysis only when there was mutual agreement that the complication could not have been caused by endotracheal intubation.
Statistical analysis
Surviving patients were compared and analyzed according to whether or not airway complications were identified. Continuous variables were analyzed using the Students t test while proportions were compared with the Fischer exact test. The 95% confidence intervals (CI) were calculated with respect to the incidence of patients presenting complications.
| Results |
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| Discussion |
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In a study evaluating use of the Combitube in the EMT algorithm for management of cardiorespiratory arrest, Lefrancois et al. reported 48 complications occurring in 760 patients.4 Although this represents a lower incidence than in the present study, Lefrancois et al. did not undertake a systematic search of complications. Recently, in a three-year retrospective review, Calkins et al. reported a 40% rate of complications with the use of the Combitube as a rescue airway device by paramedics.12 While this complication rate is higher than in the present study, the a priori definition of complications differed markedly between the two studies, as well as the indication for use of the Combitube (rescue airway device for failed endotracheal intubation vs primary airway device for cardiorespiratory arrest). Inclusion criteria were also different (all patients vs survivors of at least 12 hr). Finally, in the entirely different setting of general anesthesia in elective surgery patients, Oczenski et al. observed a much higher incidence of minor sore throat (48%) and postoperative dysphagia (68%) in comparison with patients whose airways were managed by endotracheal intubation or by insertion of a laryngeal mask airway.13
In this study, patients presenting with Combitube-related complications were younger. This difference, although statistically significant, is of uncertain clinical relevance. It is possible that the resuscitation efforts by EMTs may have been more aggressive with younger patients, thus leading to a higher complication rate. Other patient characteristics were similar in patients with or without complications.
This study has the usual limitations of a retrospective chart review: lack of a control group and reliance on the variable quality of data entered into the emergency services database, and individual patient medical records. We also limited our study population to patients surviving at least 12 hr after arrival in the emergency room. This is obviously a small subset of all patients managed with a Combitube. This decision was made a priori because it was suspected that airway complications would not have been searched or documented in the chart of deceased patients, and the value of a retrospective chart examination is such patients would have been even more limited. Certain complications might have been caused by other components of the cardiopulmonary resuscitation (CPR) procedure, leading to a potential overestimation of the true incidence of complications caused by the Combitube. We attempted to minimize this potential bias by excluding patients whose airways had also been managed by endotracheal intubation after the Combitube insertion, and who presented a complication which could have been caused by one procedure or the other.
The use of the Combitube for the management of the airway in anesthesia is probably associated with a lower incidence of serious complications because of a more controlled environment, the possibility of using a laryngoscope as an enabler, and most importantly, the airway management expertise of an anesthesiologist. However, even within the controlled setting of an operating room environment, a case of near fatal esophageal rupture has been reported.6
It has been suggested that pharyngeal and esophageal injuries have been caused by balloon overinflation as well as by the stiffness and the anterior curvature of the Combitube.14 However, these design characteristics are probably also responsible for the main advantages of the Combitube. This airway management device is relatively easy to use and studies have shown that the learning curve for its use is rather steep.3,4,15 These features make the Combitube an ideal instrument for emergency airway management by personnel without expertise in tracheal intubation during CPR. In this pre-hospital setting, the risk of complications must be weighed in context of the need to rapidly secure the patients airway and ventilate the lungs. However, in the anesthesia setting where the endotracheal tube and the laryngeal mask airway have a long track record of safety, those unique features of the Combitube are much less relevant for routine airway management.
In conclusion, use of the Combitube by emergency medical technicians in the pre-hospital setting is associated with a notable incidence of serious complications. The complications include, but are not limited to, upper airway bleeding, esophageal laceration, and esophageal perforation and mediastinitis.
| Footnotes |
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Presented in part at the 61st Annual Meeting of the Canadian Anesthesiologists Society, Vancouver, BC, June 1721, 2005.
Accepted for publication August 31, 2006. Revision accepted November 8, 2006.
| References |
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