Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients

Sponsor

Kyung Hee University Hospital at Gangdong (Other)

Overall Status

Completed

CT.gov ID

NCT06119360

Collaborator

(none)

176

Enrollment

Location

Arms

8.6

Actual Duration (Months)

20.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult or Failed	Procedure: Face-to-face approach Procedure: Conventional approach	N/A

Detailed Description

This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Comparison of the Intubation Success Rate Between Two Techniques Using Lightwand in Patients Undergoing Spine Surgery: Conventional vs. Face-to-face Technique

Actual Study Start Date :

Dec 12, 2018

Actual Primary Completion Date :

Feb 13, 2019

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Group Conventional Conventional approach using group in lightwand intubation	Procedure: Conventional approach 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
Other: Group Face-to-Face Face-to-face approach using group in lightwand intubation	Procedure: Face-to-face approach A front-facing approach and insert the lightwand following the patient's tongue base curvature without scooping movement

Arm

Intervention/Treatment

Other: Group Conventional

Conventional approach using group in lightwand intubation

Procedure: Conventional approach

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

Other: Group Face-to-Face

Face-to-face approach using group in lightwand intubation

Procedure: Face-to-face approach

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

Outcome Measures

Primary Outcome Measures

Initial success rate [during intubation]
Intubation success rate at the first attempt

Secondary Outcome Measures

Intubation time [during intubation]
Total time to the successful intubation

Other Outcome Measures

Immediate intubation related outcomes [Immediately after general anesthesia (at the post anesthesia care unit)]
Outcomes after tracheal intubation
24 hours intubation related outcomes [24 hours after general anesthesia (at the general ward)]
Outcomes after tracheal intubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Gangdong Hospital	Seoul		Korea, Republic of	05278

Sponsors and Collaborators

Kyung Hee University Hospital at Gangdong

Investigators

Principal Investigator: Hyungseok Suh, Kyung Hee University Hospital at Gangdong-gu

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyungseok Seo, Assistant professor, Kyung Hee University Hospital at Gangdong

ClinicalTrials.gov Identifier:

NCT06119360

Other Study ID Numbers:

KHNMC 2018-10-011-002

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 7, 2023