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Completed

NCT Number: NCT02611141

Retromolar Route Access With and Without A Retromolar Gap

Retromolar Intubation is a successful option for intubation in patients with an existing retromolar gap in the case that the conventional method fails.

Therefore the investigators want to test if the retromolar gap is essential for performing the retromolar intubation technique.

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Key information

Conditions

Airway Management

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

For successful endotracheal intubation an optimal visualisation of the vocal cords is essential. A study comparing retromolar and conventional laryngoscopy showed in patients with an existing retromolar gap, that the retromolar technique is superior for endotracheal intubation especially in patients with a failed 'conventional' intubation attempt. The aim of the following study is to test if a retromolar gap at the right mandible is necessary for the successful performance of the retromolar laryngoscopy technique.

Therefore, 20 patients with and 20 patients without a retromolar gap will be investigated.

The anesthesiologist will visually determine the view of the vocal cords and score it according to Cormack & Lehane. For an improved view a backward, upward, right-ward pressure (BURP) will be performed, if needed, and scored again.

Finally, endotracheal intubation will be performed by the 'conventional' intubation method. If, however, intubation is not possible, then the retromolar technique will be used. In the case that both methods fail, then any (other) intubation method will (can) be used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI < 35kg/m2
  • Elective surgery
  • Absence of at least one molar of the right mandible in arm I (20 patients)

Exclusion criteria

  • Emergency patients
  • Prevalence of reflux disease
  • Toothless patients
  • Diaphragmatic hernia
  • Patient is not sober
  • Ventilation problems during induction of anaesthesia
  • Patient with a tracheostomy

Treatment and study plan

Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane

Procedure

To facilitate the insertion of the straight blade laryngoscope (Miller #4) the head of the patient will be turned to the left side. The blade will be inserted and then pushed laterally rightwards until the retromolar space will be finally reached. Thereafter the epiglottis will be lifted up in order to achieve the best direct view to the vocal cords and scored according to Cormack & Lehane .

This score will be assessed at least 2 minutes after muscle relaxation:

  • Once without a backward, upward, rightwards pressure maneuver (=BURB) and immediately thereafter (i.e. 5-10 seconds later):
  • If 100% visualization of the vocal cords is not possible a BURP maneuver will be performed and the scored again.

Intubation will then be performed by the conventional method using a Macintosh blade #3. In the case that intubation with the conventional method is not successful the retromolar technique will be used.

Primary outcomes

  1. Cormack & Lehane score (without a backward, upward, rightwards pressure maneuver)

    Time frame: At least 2 minutes after muscle relaxation

    After ensuring sufficient bag-mask ventilation, the scoring of the vocal cords according to Cormack & Lehane will be performed at least 2 minutes after administration of the muscle relaxant rocuronium without a backward, upward, rightwards pressure maneuver (=BURB)

  2. Cormack & Lehane score (with a backward, upward, rightwards pressure maneuver)

    Time frame: Approximately 5-10 seconds after the collection of the Outcome Measure 1

    If the Outcome Measure 1 does not reveal a 100% visualization of the vocal cords, a backward, upward, rightwards pressure maneuver (BURP) maneuver will be applied and scored again according to Cormack & Lehane .

    Usually each of the two scoring procedures lasts approximately 5-10 seconds.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Retromolar Route Access With and Without A Retromolar Gap - A Visualization Study Of The Vocal Cords

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2015
Registry last updated
Mar 22, 2018

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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