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Completed

NCT Number: NCT01961817

Airway Management Via the Retromolar Route Access

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

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Key information

Conditions

Airway Management Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retromolar Vocal Cord Visualisation

Other

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.

Conventional Vocal Cord Visualisation

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Airway Management Via the Retromolar Route Access - a Clinical Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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