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Canadian Journal of Anesthesia 50:495-500 (2003)
© Canadian Anesthesiologists' Society, 2003
Cardiothoracic Anesthesia, Respiration and Airway

The PAxpressTM is an effective ventilatory device but has an 18% failure rate for flexible lightwand-guided tracheal intubation in anesthetized paralyzed patients

[Le PAxpressTM est un appareil de ventilation efficace, mais présente un taux d’échec de 18 % pour l’intubation trachéale sous guidage lumineux flexible chez les patients anesthésiés paralysés]

Vasilios Dimitriou, MD DEAA*, Gregory S. Voyagis, MD{dagger}, Christos Iatrou, MD* and Joseph Brimacombe, MB CHB FRCA MD{ddagger}

* From the Departments of Anaesthesia, University of Thrace, Greece;
{dagger} the Department of Anaesthesia and Intensive Care, Sotiria Hospital, Greece, Athens; and
{ddagger} the University of Queensland and James Cook University, Cairns Base Hospital, Cairns, Australia.

Address correspondence to: Prof. J. Brimacombe, Department of Anaesthesia and Intensive Care, Cairns Base Hospital, The Esplanade, Cairns 4870, Australia. Fax: 61 7 40311628; E-mail: jbrimaco{at}bigpond.net.au


   Abstract
TOP
 Abstract
Introduction
 Device description and insertion...
 Methods
 Results
 Discussion
 References
 
Purpose: The PAxpressTM is a new, single-use, extraglottic airway device. We evaluate: 1) insertion success rates; 2) airway sealing pressure, ventilatory capability and calculated mucosal pressures (in vitro minus in vivo intracuff pressure) at 30–60 mL cuff inflation volume; 3) the feasibility of lightwand-guided tracheal intubation; and 4) the incidence of mucosal trauma.

Methods: Ninety anesthetized, paralyzed adults were studied. Airway management was by senior anesthesiologists with no prior experience with the PAX, but considerable experience with extraglottic airway devices and the flexible-lightwand.

Results: Insertion was successful at the first attempt in 95.5% (86/90) and at the second attempt in 4.5% (4/90). Mean ± SD airway sealing pressure at 30, 40, 50 and 60 mL cuff inflation volume was 27 ± 8, 29 ± 9, 32 ± 9 and 35 ± 7 cm H2O respectively; expired tidal volume at airway sealing pressure was 16 ± 6, 18 ± 6, 19 ± 5 and 19 ± 6 mL•kg-1; and calculated mucosal pressure was 38 ± 14, 55 ± 20, 56 ± 19 and 57 ± 20 cm H2O. Airway sealing pressure, expired tidal volume at airway sealing pressure and calculated mucosal pressures increased with cuff inflation volume (all: P <= 0.0002). Esophageal leak was detected in 9% (8/90), but only at peak pressures >= 35 cm H2O and cuff inflation volumes >= 40 mL. Lightwand-guided intubation was successful in 82% (74/90) of patients. Mild, moderate and severe blood staining was detected in 40% (36/90), 15% (13/90) and 1% (1/90) respectively. Blood staining was more frequent after adjusting maneuvers (22/54 vs 32/36, P = 0.002).

Conclusion: The PAX has a high insertion success rate and is an effective ventilatory device with a low risk of gastric insufflation, but has a moderately high failure rate for lightwand-guided intubation and is associated with a relatively high incidence of mucosal trauma. Mucosal pressures may exceed pharyngeal perfusion pressure.


   Introduction
TOP
 Abstract
 Introduction
Device description and insertion...
 Methods
 Results
 Discussion
 References
 
THE PAxpressTM (PAX; Vital Signs Inc., NJ, USA) is a new extraglottic airway device that is intended to function as a ventilatory device or airway intubator for anesthesia or cardiopulmonary resuscitation (FigureGo). It was invented by Douglas R. Mongeon of Orange Park Acres, California (US Patent Number: 6,390,093). It is similar to the laryngeal tube airway1 and airway management device,2 but has a gilled distal cuff and is disposable. In this preliminary study, we evaluate: 1) insertion success rates; 2) airway sealing pressure, ventilatory capability and calculated mucosal pressures at 30–60 mL cuff inflation volume; 3) the feasibility of lightwand-guided tracheal intubation; and 4) the incidence of mucosal trauma.



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  		FIGURE The PAxpressTM.

 

   Device description and insertion technique
TOP
 Abstract
 Introduction
 Device description and insertion...
Methods
 Results
 Discussion
 References
 
The PAX is made from PVC and is single-use. It comprises an anatomically curved tube with an inflatable circular cuff in the mid-section that forms a seal in the proximal pharynx for ventilation, and a non-inflatable gilled conical tip at the distal end that forms a no-pressure seal in the hypopharynx for prevention of regurgitation and gastric insufflation. Between the cuff and tip on the inner curve is a rectangular vent that faces anteriorly towards the glottic inlet. The distal half of the vent has three vertical gills to prevent airway obstruction. The internal diameter of the airway tube is 12.3-mm and can accomodate an 8-mm cuffed tracheal tube. The pilot balloon is integral to the airway tube to prevent damage. The maximum recommended cuff inflation volume is 60 mL. There is one size for adults, but a range of sizes is planned. The deflated, lubricated PAX is held in the dominant hand like a pen. The mouth is opened (either with the non-dominant hand, a laryngoscope or by an assistant) and the PAX is advanced into the pharynx until tactile resistance is felt. The cuff is then inflated until an effective seal is obtained for ventilation or the maximum cuff inflation volume is reached.


   Methods
TOP
 Abstract
 Introduction
 Device description and insertion...
 Methods
Results
 Discussion
 References
 
After Ethical Committee approval and written informed consent, 90 consecutive ASA I–II patients scheduled for elective surgery, who required tracheal intubation, were studied. Patients were excluded if they were less than 18 yr, had respiratory tract pathology, were at risk of aspiration, or had an inter-incisor distance < 20 mm. Four senior anesthesiologists who had no prior clinical experience with the PAX, but were experienced with the flexible lightwand-guided intubation via the intubating laryngeal mask airway participated in the study. Pre-study training with the PAX comprised reading the instruction manual and manikin practice. The intracuff pressures were measured in vitro at 30–60 mL cuff inflation volume in 10-mL increments.

Anesthetic management was standardized. Monitoring was applied prior to anesthetic induction and included an electrocardiograph, pulse oximeter, gas analyzer, non-invasive blood pressure monitor, peripheral nerve stimulator, tidal volume monitor and airway pressure monitor. Anesthesia was induced with fentanyl 1 µg•kg-1 followed by propofol 1.5–3.0 mg•kg-1. Maintenance was with sevoflurane 1.5–3% in 100% oxygen. Neuromuscular blockade was achieved with cisatracurium 0.05 mg•kg-1 and maintained with 0.01 mg•kg-1 boluses to maintain a train-of-four count less than 1. Patients were ventilated via a face mask for three to five minutes.

The PAX was inserted blindly with the head/neck in the neutral position and with jaw thrust applied. A clear, water-based gel without local anesthetic was used for lubrication. The PAX was connected to a circle anesthesia breathing system and the cuff inflated with air until an effective airway was established or the maximum recommended inflation volume reached (60 mL). The criterion for an effective airway was an expired tidal volume of >= 7 mL•kg-1. If an effective airway could not be established after three insertion attempts, the anesthesiologist was free to manage the airway as clinically indicated. The number of insertion attempts was recorded. A failed attempt was defined as removal of the device from the mouth.

Once an effective airway was obtained, intracuff pressure, airway sealing pressure was determined at 30–60 mL cuff inflation volume in 10-mL increments. Airway sealing pressure was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L•min-1 and noting the airway pressure (maximum allowed was 50 cm H2O) at which equilibrium was reached.3 Esophageal leak was detected by listening over the epigastrium with a stethoscope4 and the airway pressure at which it occurred was noted. Measurements were made with gentle manual positive pressure ventilation. Expired tidal volume was determined at 30–60 mL cuff inflation volume in 10-mL increments with peak airway pressures set at 10–25 cm H2O in 5-cm H2O increments. In addition, expired tidal volume was determined with peak pressures set at airway sealing pressure. Measurements were made with the head/neck in the neutral position and the occiput on a firm pillow 7 cm in height.

Once these data were collected, a well-lubricated, straight silicone tracheal tube (Euromedical, Malaysia), preloaded with a prototype flexible lightwand,5 was inserted into the PAX and advanced beyond the distal aperture whilst observing the glow in the neck. A size 7.0 or 7.5 mm tracheal tube was used in females and a size 8.0 mm in males. Room lighting was reduced. If a glow could not be seen, the skin over the neck was stretched and/or the neck flexed/head extended to increase the thyrosternal distance. Whenever slight tactile resistance was felt, a variety of adjusting maneuvers were instituted according to the location of the light glow. If the glow was located in the midline, the following adjusting maneuvers were instituted in sequence: A) cuff deflation, withdrawal by 0.5–1.0 cm and cuff reinflation; B) extension of the neck; C) anterior pressure to the front of the neck. If the glow was in the lateral position, the following adjusting maneuvers were instituted in sequence: A) pushing from the side of the glow towards the cricoid cartilage; B) deflating the cuff, twisting the PAX by approximately 45° and simultaneously withdrawing it by 1 cm. When the tube easily advanced 8 cm beyond the distal aperture, the anesthesiologist initiated ventilation. A maximum of three intubation attempts was permitted. Between intubation attempts, the patient was ventilated via the PAX. An intubation attempt through the PAX was defined as a forward and backward movement of the tracheal tube. The number of attempts at tracheal intubation through the PAX and the depth of the PAX at the incisors after successful intubation were noted. Following successful intubation, the PAX was removed and the quantity of blood staining noted (mild: blood covering < 10% of gills; moderate: 10–20% of gills; and severe: > 20% of gills. Any episodes of hypoxia (SpO2 < 90%) were noted.

Calculated mucosal pressures were determined by subtracting in vivo from in vitro intracuff pressures. Statistical analysis was with one-way ANOVA with Bonferroni post hoc test for multiple comparisons paired, Chi-squared test and Fisher’s exact test. Significance was taken as P < 0.05.


   Results
TOP
 Abstract
 Introduction
 Device description and insertion...
 Methods
 Results
Discussion
 References
 
The mean ± SD age, weight and height was 51 ± 17 yr, 73 ± 15 kg and 165 ± 10 cm. The male:female ratio was 34:56. The number of patients managed by each anesthesiologist was 12, 15, 20 and 43. There were no differences in performance among anesthesiologists. PAX insertion was successful at the first attempt in in 95.5% (86/90) and at the second attempt in 4.5% (4/90). Airway sealing pressures, expired tidal volumes and calculated mucosal pressures are given in the TableGo. Airway sealing pressure (P < 0.0001), expired tidal volume at airway sealing pressure (P = 0.0002) and calculated mucosal pressures (P < 0.0001) increased with cuff inflation volume. Expired tidal volume at peak airway pressures 10–20 cm H2O did not increase with cuff inflation volume, but there was a slight increase at 25 cm H2O (P = 0.025). Expired tidal volume increased with peak airway pressure at all cuff inflation volumes (all: P < 0.0001). Esophageal leak was detected in 9% (8/90). The mean (range) airway sealing pressure and cuff inflation volume at which esophageal leak occurred was 37 (35–45) H2O and 51 (40–60) mL respectively. Lightwand-guided intubation was successful in 82% (74/90) of patients. Of these, 60% (54/90) were intubated at the first attempt without any adjusting maneuvers, 11% (10/90) were intubated at the first attempt with one adjusting maneuver, 6% (5/90) were intubated at the first attempt with two adjusting maneuvers, 2% (2/90) were intubated at the first attempt with three adjusting maneuvers and 4% (3/90) at the second attempt with two or three adjusting maneuvers. Lightwand-guided intubation failed in 18% (16/90) of patients. There were no episodes of esophageal intubation. Mild, moderate and severe blood staining was detected in 40% (36/90), 15% (13/90) and 1% (1/90) respectively. Blood staining was more frequent if adjusting maneuvers were required (22/54 vs 32/36, P = 0.002). There were no episodes of hypoxia or hypercapnea. The success rate for lightwand-guided intubation increased between the first and last 30 patients (21/30 vs 28/30, P = 0.04).


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  		TABLE Airway sealing pressure, expired tidal volumes at peak airway pressures 10–25 cm H2O and at airway sealing pressure, and calculated mucosal pressure at 30, 40, 50 and 60 mL intracuff inflation volume
 

   Discussion
TOP
 Abstract
 Introduction
 Device description and insertion...
 Methods
 Results
 Discussion
References
 
We found that the PAX was easy to insert with insertion success rates similar to other preliminary studies of extraglottic airway devices such as the Laryngeal Mask Airway ClassicTM,6 the Laryngeal Mask Airway FastrachTM,7 the Laryngeal Mask Airway ProSealTM,8 the Laryngeal Tube AirwayTM9 and the Cuffed Oropharyngeal AirwayTM.10 The efficacy of seal (25–35 cm H2O) was higher than the cuffed oropharyngeal airway (16–22 cm H2O)11,12 and the classic laryngeal mask airway (17–27 cm H2O),13,14 but similar to the intubating laryngeal mask airway (36–37 cm H2O),15,16 the ProSealTM Laryngeal Mask Airway (27–36 cm H2O)8,17 and Laryngeal Tube AirwayTM (30 cm H2O).9 We found that inflating the cuff from 30 to 60 mL improved the seal from 26 to 35 cm H2O. This is similar to the pattern of changing seal with cuff inflation volume found with the laryngeal tube airway.18

Esophageal leaks occurred in 8.9% of patients and at airway pressures greater than 35 cm H2O and at high cuff inflation volumes. This suggests that the gills at the distal tip form an effective seal in the hypopharynx and has implications for prevention of gastric insufflation and, possibly, prevention of regurgitation of gastric contents. By contrast, esophageal leaks with the Laryngeal Mask Airway ClassicTM occur at 20–30 cm H2O19,20 and with the Cuffed Oropharyngeal AirwayTM at probably 10–20 cm H2O.21 Gills have been shown to form an effective seal (> 40 cm H2O) with the glottis when incorporated into tracheal tube design.22

We found that flexible lightwand-guided intubation with the PAX had a first attempt insertion success rate without adjusting maneuvers of 60%, a first attempt insertion success rate with adjusting maneuvers of 79% and an overall intubation success rate of 82%. This compares with a first attempt insertion success rate without adjusting maneuvers of 62%, a first attempt insertion success rate with adjusting maneuvers of 92% and overall intubation success rate of 100% for flexible lightwand-guided intubation with the intubating laryngeal mask airway.23 We found tentative evidence for skill acquisition and speculate the intubation success rates will improve with experience and better understanding of the adjusting maneuvers. To optimize the intubation success rate, we recommend applying jaw thrust during PAX insertion and ensuring that the tube is in the midline and not pulled sideways by the anesthesia breathing system. Other potential options for intubation with the PAX include fibreoptic-guided intubation within and outside the cuff, as described for the Oesophageal Tracheal CombitubeTM.24,25

We found that calculated mucosal pressures were approximately 40–60 cm H2O. Pharyngeal mucosal perfusion is progressively reduced when mucosal pressures increase from 34 to 80 cm H2O26 suggesting that pharyngeal perfusion could potentially be impaired with the PAX. To minimize mucosal ischemic injury, cuff volume should be reduced to the minimum required to form an effective seal. We found that mucosal trauma occurred in 56% of patients. This may be related to the high mucosal pressures, but could also be caused by shearing forces during insertion, adjusting maneuvers and removal since the procedures were of short duration (25–30 min). The high incidence of trauma associated with adjusting maneuvers suggests that shearing forces are a prime factor in mucosal injury. Interestingly, the incidence of mucosal trauma with the intubating laryngeal mask airway is 23% for lightwand-guided intubation via the intubating laryngeal mask airway27 despite much higher mucosal pressures and similar numbers of adjusting maneuvers.16 Perhaps shearing injuries are less common with the intubating laryngeal mask airway.

Our study has a number of limitations. First, only one size of PAX was available and it is likely that performance would improve with a wider range since this appears to be the case for other extraglottic airway devices. Second, we did not measure mucosal pressures directly, but rather calculated them from in vitro and in vivo intracuff pressures. However, it has been shown that intracuff pressures are excellent predictors of directly measured mucosal pressures with the cuffed oropharyngeal airway that has a similar thin-walled cuff to the PAX.26 Third, although we demonstrated relatively high mucosal pressures and a high incidence of mucosal trauma, this does not necessarily equate to a higher incidence of postoperative airway morbidity.

We conclude that the PAX has a high insertion success rate and is an effective ventilatory device with a low risk of gastric insufflation, but has a moderately high failure rate for lightwand-guided intubation and is associated with a relatively high incidence of mucosal trauma. Mucosal pressures may exceed pharyngeal perfusion pressure.


   Footnotes
 
Disclosure: This study was supported solely by departmental funds.

Revision received February 12, 2003. Accepted for publication July 22, 2002.


   References
TOP
 Abstract
 Introduction
 Device description and insertion...
 Methods
 Results
 Discussion
 References
 
1 Genzwuerker HV, Hilker T, Hohner E, Kuhnert-Frey B. The laryngeal tube: a new adjunct for airway management. Prehosp Emerg Care 2000; 4: 168–72.[Medline]

2 Johnson R, Bailie R. Airway management device (AMDTM) for airway control in percutaneous dilatational tracheostomy (Letter). Anaesthesia 2000; 55: 596–7.[Medline]

3 Keller C, Brimacombe JR, Keller K, Morris R. A comparison of four methods for assessing airway sealing pressure with the laryngeal mask airway in adult patients. Br J Anaesth 1999; 82: 286–7.[Abstract/Free Full Text]

4 Brimacombe J, Keller C, Kurian S, Myles J. Reliability of epigastric auscultation to detect gastric insufflation. Br J Anaesth 2002; 88: 127–9.[Abstract/Free Full Text]

5 Dimitriou V, Voyagis GS. Use of a prototype flexible lighted catheter for guided tracheal intubation through the intubating laryngeal mask (Letter). Anesth Analg 1999; 89: 257–8.[Free Full Text]

6 Smith I, White PF. Use of the laryngeal mask airway as an alternative to a face mask during outpatient arthroscopy. Anesthesiology 1992; 77: 850–5.[Medline]

7 Kihara S, Yaguchi Y, Brimacombe J, Watanabe S, Taguchi N. Routine use of the intubating laryngeal mask airway results in increased upper airway morbidity. Can J Anesth 2001; 48: 604–8.[Abstract/Free Full Text]

8 Brimacombe J, Keller C. The ProSeal laryngeal mask airway. A randomized, crossover study with the standard laryngeal mask airway in paralyzed, anesthetized patients. Anesthesiology 2000; 93: 104–9.[Medline]

9 Asai T, Murao K, Shingu K. Efficacy of the laryngeal tube during intermittent positive-pressure ventilation. Anaesthesia 2000; 55: 1099–102.[Medline]

10 Greenberg RS, Brimacombe J, Berry A, Gouze V, Piantadosi S, Dake EM. A randomized controlled trial comparing the cuffed oropharyngeal airway and the laryngeal mask airway in spontaneously breathing anesthetized adults. Anesthesiology 1998; 88: 970–7.[Medline]

11 Brimacombe JR, Brimacombe JC, Berry AM, et al. A comparison of the laryngeal mask airway and cuffed oropharyngeal airway in anesthetized adult patients. Anesth Analg 1998; 87: 147–52.[Abstract/Free Full Text]

12 van Vlymen JM, Fu W, White PF, Klein KW, Griffin JD. Use of the cuffed oropharyngeal airway as an alternative to the laryngeal mask airway with positive-pressure ventilation. Anesthesiology 1999; 90: 1306–10.[Medline]

13 Keller C, Brimacombe J. Mucosal pressure and oropharyngeal leak pressure with the ProSeal versus laryngeal mask airway in anaesthetized patients. Br J Anaesth 2000; 85: 262–6.[Abstract/Free Full Text]

14 Brimacombe J, Keller C. Laryngeal mask airway size selection in males and females: ease of insertion, oropharyngeal leak pressure, pharyngeal mucosal pressures and anatomical position. Br J Anaesth 1999; 82: 703–7.[Abstract/Free Full Text]

15 Keller C, Brimacombe J. The intubating laryngeal mask airway in fresh cadavers vs paralysed anesthetised patients. Can J Anesth 1999; 46: 1067–9.[Abstract/Free Full Text]

16 Keller C, Brimacombe J. Pharyngeal mucosal pressures, airway sealing pressures and fiberoptic position with the intubating versus the standard laryngeal mask airway. Anesthesiology 1999; 90: 1001–6.[Medline]

17 Brimacombe J, Keller C, Boehler M, Puhringer F. Positive pressure ventilation with the ProSeal versus classic laryngeal mask airway: a randomized, crossover study of healthy female patients. Anesth Analg 2001; 93: 1351–3.[Abstract/Free Full Text]

18 Doerges V, Ocker H, Wenzel V, Schmucker P. The laryngeal tube: a new simple airway device. Anesth Analg 2000; 90: 1220–2.[Free Full Text]

19 Devitt JH, Wenstone R, Noel AG, O’Donnell MP. The laryngeal mask airway and positive-pressure ventilation. Anesthesiology 1994; 80: 550–5.[Medline]

20 Weiler N, Latorre F, Eberle B, Goedecke R, Heinrichs W. Respiratory mechanics, gastric insufflation pressure, and air leakage of the laryngeal mask airway. Anesth Analg 1997; 84: 1025–8.[Abstract]

21 Brimacombe J, Keller C. Water flow between the upper esophagus and pharynx for the LMA and COPA in fresh cadavers. Can J Anesth 1999; 46: 1064–6.[Abstract/Free Full Text]

22 Reali-Forster C, Kolobow T, Giacomini M, Hayashi T, Horiba K, Ferrans VJ. New ultrathin-walled endotracheal tube with a novel laryngeal seal design. Long-term evaluation in sheep. Anesthesiology 1996; 84: 162–72.[Medline]

23 Dimitriou V, Voyagis GS. Light-guided intubation via the intubating laryngeal mask using a prototype illuminated flexible catheter: clinical experience in 400 patients. Acta Anaesthesiol Scand 2000; 44: 1002–6.[Medline]

24 Krafft P, Roggla M, Fridrich P, Locker GJ, Frass M, Benumof JL. Bronchoscopy via a redesigned Combitube in the esophageal position. A clinical evaluation. Anesthesiology 1997; 86: 1041–5.[Medline]

25 Gaitini LA, Vaida SJ, Somri M, Fradis M, Ben-David B. Fiberoptic-guided airway exchange of the esophageal-tracheal Combitube® in spontaneously breathing versus mechanically ventilated patients. Anesth Analg 1999; 88: 193–6.[Abstract/Free Full Text]

26 Brimacombe J, Keller C, Puhringer F. Pharyngeal mucosal pressure and perfusion. A fiberoptic evaluation of the posterior pharynx in anesthetized adult patients with a modified cuffed oropharyngeal airway. Anesthesiology 1999; 91: 1661–5.[Medline]

27 Kihara S, Watanabe S, Taguchi N, Suga A, Brimacombe JR. A comparison of blind and lightwand-guided tracheal intubation through the intubating laryngeal mask. Anaesthesia 2000; 55: 427–31.[Medline]




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