Comparison of Video and Direct Laryngoscopy in Obese Patients During Surgery

Recruiting

• Conditions: Obesity Difficult Airway Airway Management

• Registration Number: NCT06973434
• Lead Sponsor: Harran University

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.

Detailed Description

Success in airway management is critical for the safety of anesthesia practices. Unsuccessful airway management is a leading cause of anesthesia-related morbidity-including airway trauma, dental injury, pulmonary aspiration, unplanned tracheostomy, hypoxic brain injury, and cardiopulmonary arrest-and mortality.

Unsuccessful airway management accounts for approximately 30-40% of anesthesia-related deaths. In a review of closed insurance claims against anesthesiologists, 17% were related to difficult or impossible intubation without documented preoperative airway assessment.

Video laryngoscopes are technological tools used to visualize airway structures and facilitate endotracheal intubation, particularly in patients with anticipated difficult airways.

Obesity is a metabolic disorder characterized by excessive fat accumulation and is associated with both physical and psychological complications. It is an independent risk factor for difficult airway and increases the risk of anesthesia-related complications. Obesity is also linked to restrictive lung disease due to increased intra-abdominal pressure and decreased thoracic compliance. The resulting reductions in static and dynamic lung volumes lead to rapid desaturation during apnea or hypoventilation, primarily due to reduced functional residual capacity and expiratory reserve volume.

In this prospective observational study, the investigators aim to perform a comparative analysis of VIDIAC scores, hemodynamic responses (heart rate, systolic and diastolic blood pressure, mean arterial pressure), and early postoperative complications following laryngoscopy performed with Storz C-MAC videolaryngoscope, Scoper videolaryngoscope, and Macintosh laryngoscope in obese patients undergoing elective surgery under general anesthesia.

Study Timeline

• Study First Submitted: 2025-04-10
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-08-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VIDIAC (Video Intubation Difficulty Assessment and Classification) Score	Immediately after intubation (within 1 minute)	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)
Heart Rate Change	Baseline to 5 minutes post-intubation	Change in heart rate from baseline (pre-induction) to 5 minutes after intubation

Secondary Outcome Measures

Name	Time	Method
Successful First-Attempt Intubation Rate	Immediately after intubation (within 1 minute)	Proportion of patients successfully intubated on the first attempt using the assigned laryngoscope device.laryngoscope.
Intubation Time	Immediately after intubation	Time measured in seconds from insertion of the laryngoscope blade to confirmation of successful endotracheal tube placement.

Trial Locations

Locations (1)

Veli Fahri Pehlivan; 🇹🇷 Şanlıurfa, Turkey