A Comparison of a Macintosh Laryngoscope and Endotracheal Tube Introducer in a Manikin

NCT03419507 | Completed DMC

• 1 other identifier: 2017/16. 15/351
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized, cross-over study, investigators aimed to compare the first pass successes of inexperienced doctors with Macintosh laryngoscopy and endotracheal tube introducer on a manikin with continuous chest compression in the ambulance simulation in the pre-hospital process.

Conditions

Difficult Intubation

Keywords

endotracheal tube introducer; manikin; chest compression

Outcome Measures

Primary Outcomes (1)

• First pass success

  The primary outcome measure of the survey is determined as the first pass success of the doctors.

  1 minute

Secondary Outcomes (3)

• intubation duration

  1 minute

• Intervention numbers

  1 minute

• Difficulty levels of the methods

  2 minutes

Study Arms (2)

Macintosh group

ACTIVE COMPARATOR

After separating participants into two groups, doctors that drawed envelop number 1 will be asked to intubate with laryngoscope by using No. 3 Macintosh laryngoscope

Device: Macintosh laryngoscopy

Endotracheal tube introducer group

ACTIVE COMPARATOR

After separating participants into two groups, doctors that drawed envelop number 2 will be asked to intubate with laryngoscope by using the adult size endotracheal tube introducer with using No. 3 Macintosh laryngoscope.

Device: Endotracheal tube introducer

Interventions

Endotracheal tube introducer DEVICE

The doctors that drawed envelop number 2 will be asked to intubate with laryngoscope by the adult size, endotracheal tube introducer with using No. 3 Macintosh blade

Endotracheal tube introducer group

Macintosh laryngoscopy DEVICE

The doctors who drawed envelope number 1 will asked to intubate with using No. 3 Macintosh blade

Macintosh group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• novice doctors who accept to participate the study

You may not qualify if:

• novice doctors who won't accept to participate the study

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince training and educational hospital

Kocaeli, Derince, 41300, Turkey (Türkiye)

Location

Related Publications (5)

• Murat I, Constant I, Maud'huy H. Perioperative anaesthetic morbidity in children: a database of 24,165 anaesthetics over a 30-month period. Paediatr Anaesth. 2004 Feb;14(2):158-66. doi: 10.1111/j.1460-9592.2004.01167.x.

  PMID: 14962332 BACKGROUND

• Bhananker SM, Ramamoorthy C, Geiduschek JM, Posner KL, Domino KB, Haberkern CM, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children: update from the Pediatric Perioperative Cardiac Arrest Registry. Anesth Analg. 2007 Aug;105(2):344-50. doi: 10.1213/01.ane.0000268712.00756.dd.

  PMID: 17646488 BACKGROUND

• Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

  PMID: 26705976 BACKGROUND

• Jabre P, Combes X, Leroux B, Aaron E, Auger H, Margenet A, Dhonneur G. Use of gum elastic bougie for prehospital difficult intubation. Am J Emerg Med. 2005 Jul;23(4):552-5. doi: 10.1016/j.ajem.2004.12.005.

  PMID: 16032630 BACKGROUND

• Kidd JF, Dyson A, Latto IP. Successful difficult intubation. Use of the gum elastic bougie. Anaesthesia. 1988 Jun;43(6):437-8. doi: 10.1111/j.1365-2044.1988.tb06625.x.

  PMID: 3407866 BACKGROUND

Related Links

• The difficult pediatric airway - UpToDate \[Internet\]. Jul 31. 2017

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The doctors will be informed about the research, but they will be blind to the specific purposes of the study
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Equal numbers 1 and 2 will be written on the same sized papers. After separating participants into two groups, doctors that drawed envelop number 1 will be asked to intubate with No. 3 Macintosh laryngoscopy and doctors that drawed envelop number 2 will be asked to intubate with endotracheal tube introducer. Than groups will be changed.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 5, 2018
• Study Start: February 10, 2018
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

TU (1)