Retromolar Route Access With and Without A Retromolar Gap

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Procedure: Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane

• Registration Number: NCT02611141
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-07
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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
• Patient with a tracheostomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient without a Retromolar Gap	Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane	20 patients without a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.
Patient with Retromolar Gap	Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane	20 patients with a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.

Primary Outcome Measures

Name	Time	Method
Cormack & Lehane score (without a backward, upward, rightwards pressure maneuver)	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)
Cormack & Lehane score (with a backward, upward, rightwards pressure maneuver)	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria