Tracheal Intubation Using Videolaryngoscope vs Fiberoptic Bronchoscope in Patients With Cervical Immobilization

NCT03759561 | Completed DMC

• 1 other identifier: VL_FOB
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with suspected cervical spine injury, cervical immobilization, such as manual in-line stabilization or cervical collar has been adopted to prevent further neurologic injury due to cervical motion. In these patients, tracheal intubation with direct laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used for tracheal intubation in such patients. In this study, the initial success rate of tracheal intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will be compared.

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

• The initial success rate

  The first-pass success was defined as successful tracheal intubation on a single attempt in all stages of tracheal intubation

  intraoperatively

Secondary Outcomes (2)

• intubation time

  intraoperatively

• the incidence of complication

  intraoperatively to 1hour and 24 hours after the surgery

Study Arms (2)

Videolaryngoscope group

ACTIVE COMPARATOR

In the videolaryngoscope group, tracheal intubation was performed using videolaryngoscope under cervical collar application.

Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscope

Fiberoptic bronchoscope group

ACTIVE COMPARATOR

In the fiberoptic bronchoscope group, tracheal intubation was performed using fiberoptic bronchoscope via oral cavity under cervical collar application.

Procedure: intubation with videolaryngoscope vs fiberoptic bronchoscope

Interventions

intubation with videolaryngoscope vs fiberoptic bronchoscope PROCEDURE

Tracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations

Fiberoptic bronchoscope group; Videolaryngoscope group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require tracheal intubation
• Adult patients aged 20-80
• American Society of anesthesiologists physical status classification Ⅰ-Ⅲ

You may not qualify if:

• patient's refusal
• patients had a high risk of aspiration, history of gastroesophageal reflux disease, coagulopathy, previous history of radiation therapy on the neck and airway surgery, and upper airway lesions (i.e., tumor, polyp, inflammation, trauma, abscess, and foreign body)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Hee-pyoung Park, MD,PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: December 14, 2018
• Primary Completion: January 17, 2022
• Study Completion: January 18, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)