LMA vs High-flow Nasal Oxygen During ECT in Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laryngeal Mask Airway, High-Flow Nasal Cannula.
- Who it may be relevant to
- Registry conditions: Electroconvulsive Therapy Treated Patients, Obesity. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy
Overview
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.
Detailed description
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.
Interventions
- Device Laryngeal Mask Airway
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. - Device High-Flow Nasal Cannula
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 outcome measures
- Incidence of hypoxia (SpO₂ <92%) during ECT [Time frame: During each ECT session (approximately 10-15 minutes)]
Secondary outcome measures (11)
- incidence of hypoxia during recovery [Time frame: During post-anesthesia recovery (approximately 30-40 minutes)]
- Lowest peripheral oxygen saturation [Time frame: From preoxygenation to recovery room discharge (approximately 1 hours)]
- Duration of hypoxia during ECT and recovery [Time frame: From preoxygenation to recovery room discharge (approximately 1 hours)]
- Lowest end-tidal CO₂ before ECT stimulation [Time frame: Baseline (immediately prior to ECT stimulation)]
- Percent (%) increase in heart rate after ECT stimulation [Time frame: During each ECT session (approximately 10-15 minutes)]
- Duration of seizure (motor and EEG) [Time frame: During each ECT session (approximately 10-15 minutes)]
- Postictal Suppression Index (PSI) [Time frame: During each ECT session (approximately 10-15 minutes)]
- Husain EEG Seizure Quality Scale [Time frame: During each ECT session (approximately 10-15 minutes)]
- Airway management failure rate (LMA reinsertion or intubation required) [Time frame: During each ECT session (approximately 10-15 minutes)]
- Number of participants with dental discomfort or tooth injury within 24 hours after ECT [Time frame: Within 24 hours after each ECT session]
- Number of participants requiring additional oxygen support during ECT [Time frame: During each ECT session (approximately 10-15 minutes)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07093372 · UEMC 2025-06-004-001