- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590739
Effect Of Left Head Rotation On Glottic View During Video Laryngoscopy In Obese Adults (LeHeR)
Effect of Left Head Rotation Manoeuvre on Glottic View as Assessed With Percentage of Glottic Opening (POGO) Score During Video Laryngoscopy in Obese Adult Patients: A Prospective Observational Study
This study aims to evaluate whether the Left Head Rotation (LeHeR) maneuver improves visualization of the vocal cords during video laryngoscopy in obese adult patients undergoing general anesthesia. Obesity is associated with increased difficulty in airway management due to excess upper airway soft tissue and altered anatomy, which may impair visualization during intubation.
In this prospective observational study, 50 adult patients with a body mass index (BMI) ≥30 kg/m² will undergo video laryngoscopy using a C-MAC D-blade. The glottic view will be assessed using the Percentage of Glottic Opening (POGO) score in the standard sniffing position and after rotating the head 45 degrees to the left (LeHeR maneuver). A difference in POGO score between the two positions will be analyzed.
Secondary outcomes include ease of intubation, number of attempts, time to successful intubation, and occurrence of complications such as desaturation or airway trauma. The study is expected to determine whether the LeHeR maneuver is a simple and effective technique to improve airway visualization in obese patients.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kalesh Divakar, MD
- Phone Number: +968 92452839
- Email: drkalesh@gmail.com
Study Contact Backup
- Name: Harihar V Hegde, MD
- Phone Number: +968 98845606
- Email: drharryhegde@yahoo.co.in
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Adult patients aged 18-65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I-III
- Scheduled for elective surgical procedures under general anesthesia requiring endotracheal intubation
Exclusion Criteria:
- Anticipated need for nasal intubation
- Facial or upper airway pathology preventing laryngoscope insertion
- Cervical spine instability or contraindication to head movement
- Pregnant patients
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation
Time Frame: Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
The Percentage of Glottic Opening (POGO) score will be assessed during video laryngoscopy in the sniffing position and after 45-degree left head rotation (LeHeR maneuver).
The difference in POGO score between the two positions will be recorded for each participant.
|
Baseline during induction of anaesthesia at the time of video laryngoscopy on Day 1 (single intra-operative assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Successful Intubation
Time Frame: During induction of anesthesia on Day 1
|
Time taken from insertion of the video laryngoscope blade into the oral cavity until successful placement of the endotracheal tube confirmed by capnography.
|
During induction of anesthesia on Day 1
|
|
Ease of Intubation
Time Frame: During tracheal intubation on Day 1
|
Ease of intubation assessed using Fremantle score as easy, modified, or unachievable based on number of attempts and need for adjuncts.
|
During tracheal intubation on Day 1
|
|
Number of Intubation Attempts
Time Frame: During tracheal intubation on Day 1
|
Number of attempts required to achieve successful tracheal intubation.
|
During tracheal intubation on Day 1
|
|
Requirement of Airway Adjuncts
Time Frame: During tracheal intubation on Day 1
|
Need for additional maneuvers such as external laryngeal manipulation, cuff inflation, or use of Magill forceps during intubation.
|
During tracheal intubation on Day 1
|
|
Incidence of Peri-intubation Complications
Time Frame: During induction of anesthesia and tracheal intubation on day 1
|
Occurrence of complications such as oxygen desaturation (SpO₂ <95%) or airway trauma during intubation.
|
During induction of anesthesia and tracheal intubation on day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MoH/CSR/26/31800
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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