Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients

NCT06119360 | Completed

• 1 other identifier: KHNMC 2018-10-011-002
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

• Initial success rate

  Intubation success rate at the first attempt

  during intubation

Secondary Outcomes (1)

• Intubation time

  during intubation

Other Outcomes (2)

• Immediate intubation related outcomes

  Immediately after general anesthesia (at the post anesthesia care unit)

• 24 hours intubation related outcomes

  24 hours after general anesthesia (at the general ward)

Study Arms (2)

Group Conventional

OTHER

Conventional approach using group in lightwand intubation

Procedure: Conventional approach

Group Face-to-Face

OTHER

Face-to-face approach using group in lightwand intubation

Procedure: Face-to-face approach

Interventions

Face-to-face approach PROCEDURE

A front-facing approach and insert the lightwand following the patient's tongue base curvature without scooping movement

Group Face-to-Face

Conventional approach PROCEDURE

Patients were positioned supine and the intubator stood above the patient's head. Opening the mouth and slightly pulling the mandible with one hand, the intubator inserted the lightwand-tracheal tube assembly at midline into the patient's mouth under the ambient light being turned off. To identify the location of the lighted tip, the intubator could move the lightwand back and forth gently, Once the red light of the tip was located at the midline of the patient's neck, the pre-launched tube was inserted smoothly into the patient's airway unless there was no resistance

Group Conventional

Eligibility Criteria

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

You may qualify if:

• adults with American Society of Anesthesiologists physical status 1-3
• patients who received scheduled spine surgery under general anesthesia

You may not qualify if:

• patients with body mass index \<18.5 kg/m2 or \>35.0 kg/m2,
• patients who previously had head and neck surgery,
• patients who are at high risk of aspiration,
• patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,
• patients who cannot sit due to severe spine deformity,
• patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Study Officials

• Hyungseok Suh

  Kyung Hee University Hospital at Gangdong-gu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: December 12, 2018
• Primary Completion: February 13, 2019
• Study Completion: August 31, 2019
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)