Airway Management Via the Retromolar Route Access

April 7, 2015 updated by: Wolfgang SCHRAMM, Medical University of Vienna

Airway Management Via the Retromolar Route Access - a Clinical Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Retromolar

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 Visualisation
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.
Other: Conventional Vocal Cord Visualisation
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.
Other: Convenvtional

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 Visualisation
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.
Other: Conventional Vocal Cord Visualisation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of vocal cord visualisation between the retromolar and the conventional method
Time Frame: 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.
After Intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1386/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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