LMA vs High-flow Nasal Oxygen During ECT in Obese Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Laryngeal Mask Airway, High-Flow Nasal Cannula.
- Кому может быть актуально
- Состояния в реестре: Electroconvulsive Therapy Treated Patients, Obesity. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство 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. - Устройство 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.
Первичные конечные точки
- Incidence of hypoxia (SpO₂ <92%) during ECT [Срок оценки: During each ECT session (approximately 10-15 minutes)]
Вторичные конечные точки (11)
- incidence of hypoxia during recovery [Срок оценки: During post-anesthesia recovery (approximately 30-40 minutes)]
- Lowest peripheral oxygen saturation [Срок оценки: From preoxygenation to recovery room discharge (approximately 1 hours)]
- Duration of hypoxia during ECT and recovery [Срок оценки: From preoxygenation to recovery room discharge (approximately 1 hours)]
- Lowest end-tidal CO₂ before ECT stimulation [Срок оценки: Baseline (immediately prior to ECT stimulation)]
- Percent (%) increase in heart rate after ECT stimulation [Срок оценки: During each ECT session (approximately 10-15 minutes)]
- Duration of seizure (motor and EEG) [Срок оценки: During each ECT session (approximately 10-15 minutes)]
- Postictal Suppression Index (PSI) [Срок оценки: During each ECT session (approximately 10-15 minutes)]
- Husain EEG Seizure Quality Scale [Срок оценки: During each ECT session (approximately 10-15 minutes)]
- Airway management failure rate (LMA reinsertion or intubation required) [Срок оценки: During each ECT session (approximately 10-15 minutes)]
- Number of participants with dental discomfort or tooth injury within 24 hours after ECT [Срок оценки: Within 24 hours after each ECT session]
- Number of participants requiring additional oxygen support during ECT [Срок оценки: During each ECT session (approximately 10-15 minutes)]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07093372 · UEMC 2025-06-004-001