NCT06973434

Brief Summary

This study aims to evaluate how intubation performed with two different brands of videolaryngoscope and the Macintosh laryngoscope during surgeries in obese patients requiring general anesthesia affects the VIDIAC score, hemodynamic response, and early postoperative complications. Complications such as sore throat, hoarseness, nausea, and vomiting will be recorded in the recovery room prior to discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

April 10, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

Video laryngoscopyObesityVIDIAC scoreStorz C-MACScoper MAC

Outcome Measures

Primary Outcomes (2)

  • VIDIAC (Video Intubation Difficulty Assessment and Classification) Score

    Airway visualization will be assessed using the Video Intubation Difficulty Assessment and Classification (VIDIAC) scoring system during intubation. The VIDIAC score ranges from 1 to 5. A lower score indicates better visualization and easier intubation, while a higher score reflects increased difficulty. Score (1-5 scale)

    Immediately after intubation (within 1 minute)

  • Heart Rate Change

    Change in heart rate from baseline (pre-induction) to 5 minutes after intubation

    Baseline to 5 minutes post-intubation

Secondary Outcomes (2)

  • Successful First-Attempt Intubation Rate

    Immediately after intubation (within 1 minute)

  • Intubation Time

    Immediately after intubation

Study Arms (3)

Group 1 (n=40) Intubated with Storz C-MAC3 video laryngoscope

Participants in this group will be intubated using the Storz C-MAC3 video laryngoscope. Preoperative difficult intubation risk, and pre- and post-induction vital signs (heart rate, systolic and diastolic blood pressure, mean arterial pressure) will be recorded. Additionally, VIDIAC scores specific to video-assisted intubation and early postoperative intubation complications will be assessed for this group.

Device: intubation

Group 2 (n=40): Intubated with Scoper MAC-3 video laryngoscope

Participants in this group will be intubated using the Scoper MAC-3 video laryngoscope. Preoperative difficult intubation assessment, pre- and post-induction hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure), VIDIAC scoring for video laryngoscopy, and postoperative airway-related complications will be evaluated.

Device: intubation

Group 3 (n=40): Control group intubated with Macintosh laryngoscope

Participants in the control group will be intubated using a standard Macintosh direct laryngoscope. Their preoperative airway risk, vital signs before and after induction, and intubation-related complications will be recorded. VIDIAC score will not be used for this group as it applies only to video laryngoscopy.

Device: intubation

Interventions

intubation

Group 1 (n=40) Intubated with Storz C-MAC3 video laryngoscopeGroup 2 (n=40): Intubated with Scoper MAC-3 video laryngoscopeGroup 3 (n=40): Control group intubated with Macintosh laryngoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of adult patients between the ages of 18 and 65 years with a body mass index (BMI) of ≥30 kg/m², classified as American Society of Anesthesiologists (ASA) physical status I or II. All participants will be scheduled for elective surgery requiring general anesthesia and endotracheal intubation. Eligible participants must meet the inclusion criteria for obesity and provide written informed consent. Patients will be excluded if they have a known or anticipated difficult airway, advanced cardiopulmonary disease, pregnancy, coagulopathy, cervical spine movement limitation, or if they are scheduled for emergency surgery.

You may qualify if:

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥30 kg/m²
  • ASA physical status I or II
  • Scheduled for elective surgery
  • Requiring endotracheal intubation
  • Provided written informed consent

You may not qualify if:

  • Refusal to participate in the study
  • ASA physical status III, IV, or V
  • Advanced cardiopulmonary disease
  • Cervical spine movement limitation
  • Pregnancy
  • Coagulopathy
  • Emergency surgery indication
  • Known or anticipated difficult airway
  • Severe anatomical deformity of the airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veli Fahri Pehlivan

Sanliurfa, 63100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Intubation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

May 15, 2025

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 20, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations