Comparison Between Laryngeal Mask and High-flow Nasal Oxygen Therapy in Obese Patients Undergoing Electroconvulsive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Incidence of hypoxia (SpO₂ <92%) during ECT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Alternating LMA and HFNC Oxygen Therapy
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.
干预措施: Laryngeal Mask Airway (Device)
Alternating LMA and HFNC Oxygen Therapy
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.
干预措施: High-Flow Nasal Cannula (Device)
结局指标
主要结局
Incidence of hypoxia (SpO₂ <92%) during ECT
时间窗: During each ECT session (approximately 10-15 minutes)
次要结局
- Airway management failure rate (LMA reinsertion or intubation required)(During each ECT session (approximately 10-15 minutes))
- Percent (%) increase in heart rate after ECT stimulation(During each ECT session (approximately 10-15 minutes))
- Postictal Suppression Index (PSI)(During each ECT session (approximately 10-15 minutes))
- Number of participants requiring additional oxygen support during ECT(During each ECT session (approximately 10-15 minutes))
- 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))
- Duration of seizure (motor and EEG)(During each ECT session (approximately 10-15 minutes))
- Husain EEG Seizure Quality Scale(During each ECT session (approximately 10-15 minutes))
- Number of participants with dental discomfort or tooth injury within 24 hours after ECT(Within 24 hours after each ECT session)
研究者
Hyunjae Im
Assistant Professor of Anesthesiology and Pain Medicine
Eulji University Hospital