Comparison of Video and Direct Laryngoscopy in Obese Patients During Surgery

NCT ID: NCT06973434

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-20

Brief Summary

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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

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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.

Conditions

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Obesity Difficult Airway Airway Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

intubation

Intervention Type 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.

intubation

Intervention Type 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.

intubation

Intervention Type DEVICE

intubation

Interventions

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intubation

intubation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harran University

OTHER

Sponsor Role lead

Responsible Party

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Veli Fahri Pehlivan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Veli Fahri Pehlivan

Sanliurfa, , Turkey (Türkiye)

Site Status RECRUITING

Veli Fahri Pehlivan

Sanliurfa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Veli F Pehlivan, Asist prof

Role: CONTACT

05327696566

Facility Contacts

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Veli F Pehlivan

Role: primary

+905327696566

Ümit Mirzaoğlu, dr

Role: backup

+905453455740

Veli Fahri Pehlivan, Asisst Prof

Role: primary

05327696566

Other Identifiers

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Ümit

Identifier Type: -

Identifier Source: org_study_id

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