Difficult Airway IntubationNCT07113171
Comparison of Video Laryngoscopy and Conventional Laryngoscopy for Safe Intubation in Adult Thyroid Surgery Patients With Anticipated Difficult Airway
A study testing Conventional Direct Laryngoscope and Video Laryngoscope in people with Difficult Airway Intubation and Airway Management During Operative Procedure, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Airway Intubation, Airway Management During Operative Procedure
- What is being tested?
- Conventional Direct Laryngoscope and Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Nov 2023to 18 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 66000
About this study
Official title: Comparison of Video Laryngoscopy Versus Conventional Laryngoscopy in Anticipated Difficult Intubation in Patients Undergoing Thyroid Surgery
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.
- Being tested
- Conventional Direct Laryngoscope, Video Laryngoscope
- Keywords
- Airway Management in Thyroid Surgery, Endotracheal Intubation Techniques, Video Laryngoscopy, Direct Laryngoscopy, Anesthesia in Thyroid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Direct LaryngoscopeDevice
Also called Direct Laryngoscope
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.
Video LaryngoscopeDevice
Also called Indirect Laryngoscope
The video laryngoscope allowed visualization of the glottis on a monitor without the need for cervical extension, facilitating intubation in anticipated difficult airway cases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Conventional Direct Laryngoscope |
| Group B - Video Laryngoscopy | Experimental | Received endotracheal intubation using video laryngoscope under general anesthesia in patients undergoing thyroid surgery. Receives: Device: Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Secondary outcomes (3)
Overall Intubation Success Rate
Successful tracheal intubation irrespective of the number of attempts required, verified by standard clinical confirmation methods (auscultation and capnography).
Measured: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Intubation Time
The time taken from the insertion of the laryngoscope blade between the teeth to confirmation of successful tracheal tube placement. Measured in seconds using a stopwatch. This outcome reflects procedural efficiency between the two techniques.
Measured: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Incidence of Immediate Oropharyngeal Injuries
Presence or absence of visible soft tissue trauma, bleeding, or other oropharyngeal injuries observed immediately after intubation through visual inspection by the anesthesiologist.
Measured: Immediately post-intubation (within 5 minutes of tube placement, intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start18 Nov 2023
- Primary completion18 May 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
- Investigators
- Muhammad Irfan Jamil, Principal investigator, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113171
- Sponsor's protocol ID
- Sheikh ZMC/H2
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngoscopy Versus Conventional Laryngoscopy in Anticipated Difficult Intubation in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT07113171
- Acronym / sponsor ID
- Sheikh ZMC/H2
- Keywords
- Airway Management in Thyroid Surgery, Endotracheal Intubation Techniques, Video Laryngoscopy, Direct Laryngoscopy, Anesthesia in Thyroid Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Conventional Laryngoscopy | Active comparator | Device: Conventional Direct LaryngoscopeReceived endotracheal intubation using conventional direct laryngoscope with a Macintosh blade, performed under general anesthesia in patients undergoing thyroid surgery. |
| Group B - Video Laryngoscopy | Experimental | Device: Video LaryngoscopeReceived endotracheal intubation using video laryngoscope under general anesthesia in patients undergoing thyroid surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Direct LaryngoscopeAlso: Direct LaryngoscopeThe 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. | Device | Group A - Conventional Laryngoscopy |
| Video LaryngoscopeAlso: Indirect LaryngoscopeThe video laryngoscope allowed visualization of the glottis on a monitor without the need for cervical extension, facilitating intubation in anticipated difficult airway cases. | Device | Group B - Video Laryngoscopy |
Primary outcome
First-Attempt Intubation Success Rate
Time frame: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Successful placement of the endotracheal tube through the vocal cords into the trachea on the first attempt, confirmed by bilateral chest auscultation and capnography.
3 secondary outcomes
Overall Intubation Success Rate
Time frame: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Intubation Time
Time frame: During intubation at the time of induction of anesthesia (Day 0, intraoperative)
Incidence of Immediate Oropharyngeal Injuries
Time frame: Immediately post-intubation (within 5 minutes of tube placement, intraoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Irfan Jamil principal investigator
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Direct Laryngoscope and Video Laryngoscope in people with Difficult Airway Intubation and Airway Management During Operative Procedure, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Attempt Intubation Success Rate (time frame: During intubation at the time of induction of anesthesia (Day 0, intraoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.