Retromolar Route Access With and Without A Retromolar Gap
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 7, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 22, 2018
March 1, 2018
1.7 years
November 7, 2015
March 21, 2018
Conditions
Keywords
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
OTHER20 patients with a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.
Patient without a Retromolar Gap
OTHER20 patients without a retromolar gap between the last erupted molar and the ascending ramus at the right lower mandible.
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.
Eligibility Criteria
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
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: 22670846BACKGROUNDDe 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: 24556912BACKGROUNDScott 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: 19572841BACKGROUNDHenderson 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: 10758437BACKGROUNDBehringer 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: 22074080BACKGROUNDLevitan 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: 20674088BACKGROUNDBonfils P. [Difficult intubation in Pierre-Robin children, a new method: the retromolar route]. Anaesthesist. 1983 Jul;32(7):363-7. German.
PMID: 6614426BACKGROUNDMartinez-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