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

Cholecystitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827110
• Other study ID #: AJIRB-MED-DE2-16-060
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 26, 2017
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist physical status class I, II

Exclusion Criteria:

• uncontrolled or limited cardiovascular disease

• abnormality of airway

• necessity for rapid sequence induction

• BMI > 30

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Device:
• fiberoptic bronchoscope
Tracheal intubation using fiberoptic bronchoscope
• pentax-airway scope
Tracheal intubation using pentax-AWS

Procedure:
• semi-rigid collar
semi-rigid collar immobilization of the cervical spine

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon	Gyeong-gi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to intubation		Time from device passing the mouth until confirmation of tracheal intubation by bronchoscope will be measured, about 2 minutes
Secondary	ease of intubation	Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)	Numeric rating scale will be assessed by practioner of fiberoptic bronchoscope for intubation immediately after intubation.