Clinical trial NCT06973434: Comparison of Video and Direct Laryngoscopy in Obese Patients During Surgery
Official title: "Effects of Conventional and Video Laryngoscopy Methods on VIDIAC Scores and Hemodynamic Stability in Obese Patients: Comparison of Storz C-MAC3, Scoper MAC-3 and Macintosh"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity Difficult Airway Airway Management
Keywords: Video laryngoscopy
Obesity
VIDIAC score
Storz C-MAC
Scoper MAC
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VIDIAC (Video Intubation Difficulty Assessment and Classification) Score
timeFrame: Immediately after intubation (within 1 minute)
measure: Heart Rate Change
timeFrame: Baseline to 5 minutes post-intubation
Secondary outcomes:
measure: Successful First-Attempt Intubation Rate
timeFrame: Immediately after intubation (within 1 minute)
measure: Intubation Time
timeFrame: Immediately after intubation
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Veli Fahri Pehlivan
city: Şanlıurfa
country: Turkey
facility: Veli Fahri Pehlivan
Study officials:
References: