NCT07113171

Brief Summary

This clinical study is designed to compare two different techniques used for inserting a breathing tube (a process known as intubation) in adult patients undergoing thyroid surgery who are predicted to have a difficult airway. A difficult airway refers to a situation where it may be challenging to place the breathing tube due to specific anatomical or physical factors such as restricted neck movement, enlarged thyroid gland (goiter), reduced mouth opening, short neck, or increased soft tissue around the neck. The two techniques being assessed are conventional direct laryngoscopy, which is the traditional method requiring neck extension for a direct view of the windpipe, and video laryngoscopy, a modern approach that uses a camera to visualize the vocal cords on a screen with less need for neck manipulation. In this randomized controlled trial, a total of 60 patients meeting the eligibility criteria will be included and randomly assigned into two equal groups. One group will undergo intubation using the conventional laryngoscope, while the other group will be intubated using the video laryngoscope. The primary aim of this research is to evaluate which method provides a higher success rate of placing the endotracheal tube correctly on the first attempt. Additional outcomes that will be assessed include the total time taken for intubation, whether the intubation was ultimately successful regardless of the number of attempts, and the occurrence of any immediate injuries within the mouth or throat area during or after the procedure. The underlying hypothesis of the study is that video laryngoscopy will result in a significantly higher first-attempt intubation success rate as compared to conventional laryngoscopy in patients with predicted difficult airways. This study intends to provide clinically useful evidence to guide anesthesiologists in selecting the most effective and safe intubation technique for patients undergoing thyroid surgery, with the goal of minimizing complications and improving procedural outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 2, 2025

Last Update Submit

August 2, 2025

Conditions

Keywords

Airway Management in Thyroid SurgeryEndotracheal Intubation TechniquesVideo LaryngoscopyDirect LaryngoscopyAnesthesia in Thyroid Disorders

Outcome Measures

Primary Outcomes (1)

  • First-Attempt Intubation Success Rate

    Successful placement of the endotracheal tube through the vocal cords into the trachea on the first attempt, confirmed by bilateral chest auscultation and capnography.

    During intubation at the time of induction of anesthesia (Day 0, intraoperative)

Secondary Outcomes (3)

  • Overall Intubation Success Rate

    During intubation at the time of induction of anesthesia (Day 0, intraoperative)

  • Intubation Time

    During intubation at the time of induction of anesthesia (Day 0, intraoperative)

  • Incidence of Immediate Oropharyngeal Injuries

    Immediately post-intubation (within 5 minutes of tube placement, intraoperative)

Study Arms (2)

Group A - Conventional Laryngoscopy

ACTIVE COMPARATOR

Received endotracheal intubation using conventional direct laryngoscope with a Macintosh blade, performed under general anesthesia in patients undergoing thyroid surgery.

Device: Conventional Direct Laryngoscope

Group B - Video Laryngoscopy

EXPERIMENTAL

Received endotracheal intubation using video laryngoscope under general anesthesia in patients undergoing thyroid surgery.

Device: Video Laryngoscope

Interventions

The Macintosh laryngoscope blade was used for intubation. The technique involved neck extension to create a direct line of sight to the vocal cords for successful tracheal tube placement.

Also known as: Direct Laryngoscope
Group A - Conventional Laryngoscopy

The video laryngoscope allowed visualization of the glottis on a monitor without the need for cervical extension, facilitating intubation in anticipated difficult airway cases.

Also known as: Indirect Laryngoscope
Group B - Video Laryngoscopy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 60 years
  • Both genders will be included
  • Patients requiring endotracheal intubation under general anaesthesia for thyroid surgery.
  • Patients with anticipated difficult intubation based on the preoperative airway assessment.
  • Patients having ASA (American College of Anaesthesiologists) class 1 to 2.

You may not qualify if:

  • Patients having neck injury
  • Patients having cervical spondylopathy
  • Patients requiring urgent/ emergency thyroid surgery
  • Patients with existing oropharyngeal or laryngeal abnormalities.
  • Patients with a history of severe cardiovascular or respiratory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 66000, Pakistan

Location

Study Officials

  • Muhammad Irfan Jamil

    Sheikh Zayed Medical college/Hospital, Rahimyar Khan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2025

First Posted

August 8, 2025

Study Start

November 18, 2023

Primary Completion

May 18, 2024

Study Completion

May 18, 2024

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations