NCT02611141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

November 7, 2015

Last Update Submit

March 21, 2018

Conditions

Keywords

Retromolar Intubation

Outcome Measures

Primary Outcomes (2)

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

    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)

    At least 2 minutes after muscle relaxation

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

    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.

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

Study Arms (2)

Patient with Retromolar Gap

OTHER

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

Patient without a Retromolar Gap

OTHER

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

Interventions

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: 1. Once without a backward, upward, rightwards pressure maneuver (=BURB) and immediately thereafter (i.e. 5-10 seconds later): 2. 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.

Patient with Retromolar GapPatient without a Retromolar Gap

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (8)

  • Ranieri D Jr, Filho SM, Batista S, do Nascimento P Jr. Comparison of Macintosh and Airtraq laryngoscopes in obese patients placed in the ramped position. Anaesthesia. 2012 Sep;67(9):980-5. doi: 10.1111/j.1365-2044.2012.07200.x. Epub 2012 Jun 1.

    PMID: 22670846BACKGROUND
  • De Jong A, Molinari N, Conseil M, Coisel Y, Pouzeratte Y, Belafia F, Jung B, Chanques G, Jaber S. Video laryngoscopy versus direct laryngoscopy for orotracheal intubation in the intensive care unit: a systematic review and meta-analysis. Intensive Care Med. 2014 May;40(5):629-39. doi: 10.1007/s00134-014-3236-5. Epub 2014 Feb 21.

    PMID: 24556912BACKGROUND
  • Scott J, Baker PA. How did the Macintosh laryngoscope become so popular? Paediatr Anaesth. 2009 Jul;19 Suppl 1:24-9. doi: 10.1111/j.1460-9592.2009.03026.x.

    PMID: 19572841BACKGROUND
  • Henderson JJ. Questions about the macintosh laryngoscope and technique of laryngoscopy. Eur J Anaesthesiol. 2000 Jan;17(1):2-5. doi: 10.1046/j.1365-2346.2000.00611.x. No abstract available.

    PMID: 10758437BACKGROUND
  • Behringer EC, Kristensen MS. Evidence for benefit vs novelty in new intubation equipment. Anaesthesia. 2011 Dec;66 Suppl 2:57-64. doi: 10.1111/j.1365-2044.2011.06935.x.

    PMID: 22074080BACKGROUND
  • Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.

    PMID: 20674088BACKGROUND
  • Bonfils P. [Difficult intubation in Pierre-Robin children, a new method: the retromolar route]. Anaesthesist. 1983 Jul;32(7):363-7. German.

    PMID: 6614426BACKGROUND
  • Martinez-Lage JL, Eslava JM, Cebrecos AI, Marcos O. Retromolar intubation. J Oral Maxillofac Surg. 1998 Mar;56(3):302-5; discussion 305-6. doi: 10.1016/s0278-2391(98)90103-3.

    PMID: 9496840BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao Univ. Prof. Dr. med. univ.

Study Record Dates

First Submitted

November 7, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations