LMA vs High-flow Nasal Oxygen During ECT in Obese Patients

NCT07093372 | Not Yet Recruiting

• 1 other identifier: UEMC 2025-06-004-001
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare two oxygenation strategies-laryngeal mask airway (LMA) ventilation and high-flow nasal cannula (HFNC)-during electroconvulsive therapy (ECT) in obese patients. Due to their physiological characteristics, obese patients are at increased risk of hypoxia during ECT under general anesthesia. Adult patients with a body mass index (BMI) ≥30 who are scheduled to undergo ECT will participate. Each participant will receive both oxygenation strategies in a fixed alternating order during four consecutive ECT sessions. The procedures will follow standard anesthesia protocols. During the ECT procedures and the 30-minute recovery period in the post-anesthesia care unit, we will monitor the occurrence of hypoxia (SpO₂ \<92%), ventilator parameters, vital signs, postoperative confusion within 24 hours, and any reports of dental discomfort. This information will help assess the safety and clinical utility of each oxygenation method for obese patients receiving ECT.

Conditions

Electroconvulsive Therapy Treated Patients; Obesity

Keywords

electroconvulsive therapy; obesity; ventilation strategy

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia (SpO₂ <92%) during ECT

  During each ECT session (approximately 10-15 minutes)

Secondary Outcomes (11)

• incidence of hypoxia during recovery

  During post-anesthesia recovery (approximately 30-40 minutes)

• Lowest peripheral oxygen saturation

  From preoxygenation to recovery room discharge (approximately 1 hours)

• Duration of hypoxia during ECT and recovery

  From preoxygenation to recovery room discharge (approximately 1 hours)

• Lowest end-tidal CO₂ before ECT stimulation

  Baseline (immediately prior to ECT stimulation)

• Percent (%) increase in heart rate after ECT stimulation

  During each ECT session (approximately 10-15 minutes)

Study Arms (1)

Alternating LMA and HFNC Oxygen Therapy

EXPERIMENTAL

All participants will undergo laryngeal mask airway (LMA) ventilation during ECT sessions 1 and 3, and high-flow nasal cannula (HFNC) oxygen therapy during sessions 2 and 4.

Device: Laryngeal Mask Airway; Device: High-Flow Nasal Cannula

Interventions

Laryngeal Mask Airway DEVICE

A supraglottic airway device (i-gel) used to deliver oxygen and assist ventilation during electroconvulsive therapy (ECT) in obese patients. The device is inserted after induction of general anesthesia and removed after spontaneous respiration is restored.

Alternating LMA and HFNC Oxygen Therapy

High-Flow Nasal Cannula DEVICE

A heated and humidified oxygen delivery system that provides high flow oxygen through nasal prongs. In this study, it is used throughout the ECT procedure to maintain oxygenation in obese patients without the need for invasive airway insertion.

Alternating LMA and HFNC Oxygen Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients scheduled to undergo ≥ 4 electroconvulsive therapy (ECT) sessions
• Body mass index (BMI) ≥ 30 kg/m² (WHO obesity classification)
• American Society of Anesthesiologists (ASA) physical status class I to III
• Provided written informed consent (by patient or legal guardian)

You may not qualify if:

• Patients under 18 years of age
• Patients with ASA class IV or V
• Patients with anticipated dental injury risk that precludes use of a laryngeal mask airway
• Patients or guardians who refuse participation

Sponsors & Collaborators

• Eulji University Hospital: lead

MeSH Terms

Conditions

Obesity

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Pain Medicine

Model Details: All participants will undergo LMA in session 1 and 3, and HFNC in session 2 and 4.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share