NCT01961817

Brief Summary

Is there a difference in vocal cord visualization between the retromolar and conventional access?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

October 8, 2013

Last Update Submit

April 7, 2015

Conditions

Keywords

RetromolarDifficult Intubation

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

OTHER

Patients 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.

Other: Retromolar Vocal Cord VisualisationOther: Conventional Vocal Cord Visualisation

Convenvtional

OTHER

Patients 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.

Other: Retromolar Vocal Cord VisualisationOther: Conventional Vocal Cord Visualisation

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.

ConvenvtionalRetromolar

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.

ConvenvtionalRetromolar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 19032323BACKGROUND
  • Behringer 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: 22074080BACKGROUND
  • Cooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. doi: 10.1007/BF03021900.

    PMID: 17197469BACKGROUND
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PMID: 6507827BACKGROUND
  • De 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: 12358665BACKGROUND
  • Dhonneur 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: 19302647BACKGROUND
  • Henderson 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: 9203882BACKGROUND
  • Henderson 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: 15200543BACKGROUND
  • Honarmand 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: 18471331BACKGROUND
  • Lee 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: 19542879BACKGROUND
  • Levitan 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: 20674088BACKGROUND
  • Mallampati 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: 4027773BACKGROUND
  • Sahin 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: 22826182BACKGROUND
  • Scott 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: 19572841BACKGROUND
  • Suzuki 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: 18500622BACKGROUND
  • Takahata 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: 9024040BACKGROUND
  • Tanoubi 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: 19399574BACKGROUND
  • Thong 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: 22956530BACKGROUND
  • Truong 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: 21347739BACKGROUND
  • Turkstra 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: 19512871BACKGROUND
  • Weingart 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

Locations