Airway Management Via the Retromolar Route Access
1 other identifier
interventional
100
1 country
1
Brief Summary
Is there a difference in vocal cord visualization between the retromolar and conventional access?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 8, 2015
April 1, 2015
1.7 years
October 8, 2013
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of vocal cord visualisation between the retromolar and the conventional method
In our present clinical trial we intend to compare the vocal cord visualisation by using the retromolar access compared to conventional intubation technique. Visualisation will be performed by randomized sequence and both methods will be performed in each patient. When no 100% visualisation of the vocal cords is achievable, a BURP (backward upward rightward pressure) manoeuvre will be performed. The same procedure will be performed for the another technique as well. For each trial, the anaesthesist has max. 30 seconds time for the vocal cord visualisation and scoring, which includes also the performance of the BURP-manoeuvre. Thereafter, and between each of the vocal cord visualizations as well, the patient will be ventilated by 100% oxygen for at least 20 seconds to reach at least 97% SpO2. Then intubation is performed in all patients by the conventional methode, and if intubation fails the retromolar technique, if possible.
After Intubation
Study Arms (2)
Retromolar
OTHERPatients in whom the vocal cord visualisation starts with the retromolar method, which has been randomized determined preoperatively. The second visualization then will be performed with the conventional method.
Convenvtional
OTHERPatients in whom the vocal cord visualisation starts with the conventional method, which has been randomized determined preoperatively. The second visualization then will be performed with the retromolar method.
Interventions
For easier insertion of the laryngoscope the head of the patient will be turned to the left site. Thereafter the blade (Miller) will be inserted into the mouth and pushed carefully as far as possible laterally to receive a direct view of the vocal cords. Then the performing anesthesiologist determine the Cormack \& Lehane score without and thereafter with a BURP (backward upward rightward pressure) maneuver.
The head of the patient will be positioned as usual. After 2 minutes oxygen insufflation the laryngoscope will be inserted laterally to push the tongue to the left side in order to release the sight to the vocal cords. Thereafter the anesthesiologist determines the Cormack \& Lehane score without and thereafter with performance of the BURP (backward upward rightward pressure) maneuver.
Eligibility Criteria
You may qualify if:
- Age \> 18yr
- BMI \< 30kg/m2
- Elective surgery
- Absence of at least one molar of the right mandible
You may not qualify if:
- Emergency patients
- Prevalence of reflux disease
- Toothless patients
- Diaphragmatic hernia
- Patient is not sober
- Ventilation problems during induction of anaesthesia
- Gastric regurgitation during induction of anaesthesia
- Patient with a tracheostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, Vienna, 1090, Austria
Related Publications (21)
Beckmann LA, Edwards MJ, Greenland KB. Differences in two new rigid indirect laryngoscopes. Anaesthesia. 2008 Dec;63(12):1385-6. doi: 10.1111/j.1365-2044.2008.05777.x. No abstract available.
PMID: 19032323BACKGROUNDBehringer EC, Kristensen MS. Evidence for benefit vs novelty in new intubation equipment. Anaesthesia. 2011 Dec;66 Suppl 2:57-64. doi: 10.1111/j.1365-2044.2011.06935.x.
PMID: 22074080BACKGROUNDCooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. doi: 10.1007/BF03021900.
PMID: 17197469BACKGROUNDCormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PMID: 6507827BACKGROUNDDe Beer DA, Williams DG, Mackersie A. An unexpected difficult laryngoscopy. Paediatr Anaesth. 2002 Sep;12(7):645-8. doi: 10.1046/j.1460-9592.2002.00857.x.
PMID: 12358665BACKGROUNDDhonneur G, Abdi W, Amathieu R, Ndoko S, Tual L. Optimising tracheal intubation success rate using the Airtraq laryngoscope. Anaesthesia. 2009 Mar;64(3):315-9. doi: 10.1111/j.1365-2044.2008.05757.x.
PMID: 19302647BACKGROUNDHenderson JJ. The use of paraglossal straight blade laryngoscopy in difficult tracheal intubation. Anaesthesia. 1997 Jun;52(6):552-60. doi: 10.1111/j.1365-2222.1997.129-az0125.x.
PMID: 9203882BACKGROUNDHenderson JJ, Popat MT, Latto IP, Pearce AC; Difficult Airway Society. Difficult Airway Society guidelines for management of the unanticipated difficult intubation. Anaesthesia. 2004 Jul;59(7):675-94. doi: 10.1111/j.1365-2044.2004.03831.x.
PMID: 15200543BACKGROUNDHonarmand A, Safavi MR. Prediction of difficult laryngoscopy in obstetric patients scheduled for Caesarean delivery. Eur J Anaesthesiol. 2008 Sep;25(9):714-20. doi: 10.1017/S026502150800433X. Epub 2008 May 9.
PMID: 18471331BACKGROUNDLee SS, Huang SH, Wu SH, Sun IF, Chu KS, Lai CS, Chen YL. A review of intraoperative airway management for midface facial bone fracture patients. Ann Plast Surg. 2009 Aug;63(2):162-6. doi: 10.1097/SAP.0b013e3181855156.
PMID: 19542879BACKGROUNDLevitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
PMID: 20674088BACKGROUNDMallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.
PMID: 4027773BACKGROUNDSahin M, Anglade D, Buchberger M, Jankowski A, Albaladejo P, Ferretti GR. Case reports: iatrogenic bronchial rupture following the use of endotracheal tube introducers. Can J Anaesth. 2012 Oct;59(10):963-7. doi: 10.1007/s12630-012-9763-z. Epub 2012 Jul 24.
PMID: 22826182BACKGROUNDScott J, Baker PA. How did the Macintosh laryngoscope become so popular? Paediatr Anaesth. 2009 Jul;19 Suppl 1:24-9. doi: 10.1111/j.1460-9592.2009.03026.x.
PMID: 19572841BACKGROUNDSuzuki A, Abe N, Sasakawa T, Kunisawa T, Takahata O, Iwasaki H. Pentax-AWS (Airway Scope) and Airtraq: big difference between two similar devices. J Anesth. 2008;22(2):191-2. doi: 10.1007/s00540-007-0603-1. Epub 2008 May 25. No abstract available.
PMID: 18500622BACKGROUNDTakahata O, Kubota M, Mamiya K, Akama Y, Nozaka T, Matsumoto H, Ogawa H. The efficacy of the "BURP" maneuver during a difficult laryngoscopy. Anesth Analg. 1997 Feb;84(2):419-21. doi: 10.1097/00000539-199702000-00033.
PMID: 9024040BACKGROUNDTanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
PMID: 19399574BACKGROUNDThong SY, Wong TG. Clinical uses of the Bonfils Retromolar Intubation Fiberscope: a review. Anesth Analg. 2012 Oct;115(4):855-66. doi: 10.1213/ANE.0b013e318265bae2. Epub 2012 Sep 5.
PMID: 22956530BACKGROUNDTruong A, Truong DT. Retromolar fibreoptic orotracheal intubation in a patient with severe trismus undergoing nasal surgery. Can J Anaesth. 2011 May;58(5):460-3. doi: 10.1007/s12630-011-9474-x. Epub 2011 Feb 24.
PMID: 21347739BACKGROUNDTurkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f.
PMID: 19512871BACKGROUNDWeingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PMID: 22050948BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ao Univ. Prof. Dr.
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 11, 2013
Study Start
July 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 8, 2015
Record last verified: 2015-04