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

ConditionsElectroconvulsive Therapy Treated PatientsObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorEulji University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Alternating LMA and HFNC Oxygen TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of hypoxia (SpO₂ <92%) during ECT

Time frame
During each ECT session (approximately 10-15 minutes)

Secondary outcomes

1

incidence of hypoxia during recovery

Time frame
During post-anesthesia recovery (approximately 30-40 minutes)
2

Lowest peripheral oxygen saturation

Time frame
From preoxygenation to recovery room discharge (approximately 1 hours)
3

Duration of hypoxia during ECT and recovery

Time frame
From preoxygenation to recovery room discharge (approximately 1 hours)
4

Lowest end-tidal CO₂ before ECT stimulation

Time frame
Baseline (immediately prior to ECT stimulation)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eulji University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: