Airway Management Via the Retromolar Route Access

Not Applicable

Completed

• Conditions: Airway Management; Intubation
• Interventions: Other: Retromolar Vocal Cord Visualisation; Other: Conventional Vocal Cord Visualisation

• Registration Number: NCT01961817
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Management of the difficult airway is still an essential part of modern anaesthesia. Up to now, there have bee no clinical investigations comparing the intubation method via the retromolar route (RM), with the conventional intubation route (CM).

For the present clinical investigation, 100 patients undergoing elective surgery will be investigated in the General Hospital of Vienna when for the anaesthesia intubation is required. In both intubation methods (RM and CM) the anaesthesiologist will visually determine the Cormack \& Lehane score in a randomly assigned sequence with and without a BURP-manoeuvre (= backwards, upwards and rightwards pressure). Thereafter intubation is performed in all patients by the CM method and if intubation fails the RM technique will be used. Of course, as per usual, every intubation trial is interrupted by a 20 second 100%-oxygen-ventilation period to reach a pulse oximetry oxygen saturation of at least 97% SpO2. Thereafter, if intubation fails again every other intubation technique will be applied, as necessary and called for.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 18yr
• BMI < 30kg/m2
• Elective surgery
• Absence of at least one molar of the right mandible

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Convenvtional	Retromolar Vocal Cord Visualisation	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.
Convenvtional	Conventional Vocal Cord Visualisation	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.
Retromolar	Retromolar Vocal Cord Visualisation	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.
Retromolar	Conventional Vocal Cord Visualisation	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.

Primary Outcome Measures

Name	Time	Method
Comparison of vocal cord visualisation between the retromolar and the conventional method	After Intubation	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria