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OpenTrials
Completed

NCT Number: NCT02827110

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiberoptic bronchoscope

Device

Tracheal intubation using fiberoptic bronchoscope

pentax-airway scope

Device

Tracheal intubation using pentax-AWS

semi-rigid collar

Procedure

semi-rigid collar immobilization of the cervical spine

Primary outcomes

  1. time to intubation

    Time frame: 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

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

    Numeric rating scale 0-10 (0:easy without any difficulty, 10: impossible to intubate)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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