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

NCT ID: NCT02827110

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholecystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fiberoptic bronchoscope

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

Group Type ACTIVE_COMPARATOR

fiberoptic bronchoscope

Intervention Type DEVICE

Tracheal intubation using fiberoptic bronchoscope

semi-rigid collar

Intervention Type PROCEDURE

semi-rigid collar immobilization of the cervical spine

fiberoptic bronchoscope with pentax-AWS

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

Group Type EXPERIMENTAL

fiberoptic bronchoscope

Intervention Type DEVICE

Tracheal intubation using fiberoptic bronchoscope

pentax-airway scope

Intervention Type DEVICE

Tracheal intubation using pentax-AWS

semi-rigid collar

Intervention Type PROCEDURE

semi-rigid collar immobilization of the cervical spine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fiberoptic bronchoscope

Tracheal intubation using fiberoptic bronchoscope

Intervention Type DEVICE

pentax-airway scope

Tracheal intubation using pentax-AWS

Intervention Type DEVICE

semi-rigid collar

semi-rigid collar immobilization of the cervical spine

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yun jeong chae

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28981579 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AJIRB-MED-DE2-16-060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ETI During Spinal Trauma
NCT02295631 UNKNOWN NA