Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone

NCT02827110 | Completed

• 1 other identifier: AJIRB-MED-DE2-16-060
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A semi-rigid cervical collar is recommended for immobilization of the cervical spine in patients with cervical spine injury. It has been suggested that a reduction in mouth opening is the major contributing factor to the deterioration in the glottic view obtained. Fiberoptic intubation is among the most versatile techniques for managing both the anticipated and the unanticipated difficult airway. Recently, combination of fiberoptic bronchoscope with videolaryngoscope has been suggested to permit visual control of the passage of the tube over the fibrescope into the laryngeal inlet. The aim of this study is to compare the intubation time and ease of intubation between fiberoptic bronchoscope alone and bronchoscope with pentax airwayscope.

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

• time to intubation

  Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes

Secondary Outcomes (1)

• ease of intubation

  Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.

Study Arms (2)

fiberoptic bronchoscope

ACTIVE COMPARATOR

Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope

Device: fiberoptic bronchoscope; Procedure: semi-rigid collar

fiberoptic bronchoscope with pentax-AWS

EXPERIMENTAL

Tracheal intubation in patients with semi-rigid collar immobilization of the cervical spine using fiberoptic bronchoscope with pentax-AWS

Device: fiberoptic bronchoscope; Device: pentax-airway scope; Procedure: semi-rigid collar

Interventions

fiberoptic bronchoscope DEVICE

Tracheal intubation using fiberoptic bronchoscope

fiberoptic bronchoscope; fiberoptic bronchoscope with pentax-AWS

pentax-airway scope DEVICE

Tracheal intubation using pentax-AWS

fiberoptic bronchoscope with pentax-AWS

semi-rigid collar PROCEDURE

semi-rigid collar immobilization of the cervical spine

fiberoptic bronchoscope; fiberoptic bronchoscope with pentax-AWS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist physical status class I, II

You may not qualify if:

• uncontrolled or limited cardiovascular disease
• abnormality of airway
• necessity for rapid sequence induction
• BMI \> 30

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Location

Related Publications (1)

• Kim DH, Yoo JY, Ha SY, Chae YJ. Comparison of the paediatric blade of the Pentax-AWS and Ovassapian airway in fibreoptic tracheal intubation in patients with limited mouth opening and cervical spine immobilization by a semi-rigid neck collar: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):993-999. doi: 10.1093/bja/aex272.

  PMID: 28981579 DERIVED

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 11, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

KR (1)