NCT07590739

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress9%
May 2026Jan 2027

First Submitted

Initial submission to the registry

April 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

April 30, 2026

Last Update Submit

May 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Percentage of Glottic Opening (POGO) Score between Sniffing Position and Left Head Rotation

    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 Outcomes (5)

  • Time to Successful Intubation

    During induction of anesthesia on Day 1

  • Ease of Intubation

    During tracheal intubation on Day 1

  • Number of Intubation Attempts

    During tracheal intubation on Day 1

  • Requirement of Airway Adjuncts

    During tracheal intubation on Day 1

  • Incidence of Peri-intubation Complications

    During induction of anesthesia and tracheal intubation on day 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-65 years with body mass index (BMI) ≥30 kg/m², classified as ASA physical status II-III, undergoing elective surgical procedures under general anesthesia requiring orotracheal intubation at a tertiary care hospital.

You may qualify if:

  • 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

You may not qualify if:

  • Anticipated need for nasal intubation
  • Facial or upper airway pathology preventing laryngoscope insertion
  • Cervical spine instability or contraindication to head movement
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Kalesh Divakar, MD

CONTACT

Harihar V Hegde, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 15, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies and to ensure protection of participant confidentiality. Data may be made available upon reasonable request to the corresponding author, subject to institutional review and approval.