Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients

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

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

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Procedure: Conventional approach; Procedure: Face-to-face approach

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 Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Gangdong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial success rate	Intubation success rate at the first attempt	during intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Total time to the successful intubation	during intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate intubation related outcomes	Outcomes after tracheal intubation	Immediately after general anesthesia (at the post anesthesia care unit)
24 hours intubation related outcomes	Outcomes after tracheal intubation	24 hours after general anesthesia (at the general ward)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KHNMC 2018-10-011-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No