Retromolar Route Access With and Without A Retromolar Gap

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02611141
Collaborator
(none)
40
1
2
20
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Retromolar Route Access With and Without A Retromolar Gap - A Visualization Study Of The Vocal Cords
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Patient with Retromolar Gap

20 patients with a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.

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

Other: Patient without a Retromolar Gap

20 patients without a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.

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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wolfgang SCHRAMM, Ao Univ. Prof. Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02611141
Other Study ID Numbers:
  • 1848/2015
First Posted:
Nov 20, 2015
Last Update Posted:
Mar 22, 2018
Last Verified:
Mar 1, 2018
Keywords provided by Wolfgang SCHRAMM, Ao Univ. Prof. Dr. med. univ., Medical University of Vienna

Study Results

No Results Posted as of Mar 22, 2018