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NCT Number: NCT07093372

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

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.

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Key information

Conditions

Electroconvulsive Therapy Treated Patients Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Obesity is a known risk factor for perioperative hypoxia due to physiological changes such as increased airway resistance, reduced functional residual capacity, and elevated oxygen demand. These risks are amplified in patients undergoing electroconvulsive therapy (ECT) under general anesthesia, where periods of apnea can result in critical oxygen desaturation.

While laryngeal mask airways (LMAs) and high-flow nasal cannula (HFNC) therapy are both recommended strategies to maintain oxygenation during anesthesia, their comparative effectiveness in obese patients undergoing ECT has not been well established. LMAs provide direct airway access and enable positive pressure ventilation but carry a risk of dental trauma. HFNC offers a non-invasive alternative that may prolong safe apnea time, though its oxygenation efficacy during ECT remains unclear.

This study aims to evaluate the safety and effectiveness of LMA versus HFNC in preventing hypoxia during ECT in obese patients. Using a within-subject crossover design, each participant will receive both interventions in alternating ECT sessions. This trial will help determine the optimal airway management strategy for minimizing peri-procedural hypoxia in this high-risk population.

The outcome will be assessed during each ECT session as part of a crossover design. All participants will undergo both LMA and HFNC interventions in alternating sessions (LMA during sessions 1 and 3, HFNC during sessions 2 and 4). Oxygen support beyond the assigned method will be recorded when clinically indicated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

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)

  5. Percent (%) increase in heart rate after ECT stimulation

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

  6. Duration of seizure (motor and EEG)

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

  7. Postictal Suppression Index (PSI)

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

  8. Husain EEG Seizure Quality Scale

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

  9. Airway management failure rate (LMA reinsertion or intubation required)

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

  10. Number of participants with dental discomfort or tooth injury within 24 hours after ECT

    Time frame: Within 24 hours after each ECT session

  11. Number of participants requiring additional oxygen support during ECT

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

Sponsors and collaborators

Lead sponsor

Eulji University Hospital

Other

Registry information

Official study title

Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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