Does Residual Muscular Weakness Lead to an Increase in Respiratory Complications in Bariatric Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Respiratory Events (RE)
研究概览
简要总结
The purpose of this study is to determine if residual weakness after weight loss surgery leads to an increased risk of respiratory complications in the postoperative period.
详细描述
Patients interested in bariatric surgery would contact Dr. Marema or Dr. Koppman. Dr. Marema and Dr. Koppman will determine, if patients qualify for bariatric surgery. Patients will undergo a thorough preoperative workup. After optimization of all medical conditions patients would be scheduled for bariatric surgery. This is our current clinical practice.
One of the investigators would determine if a patient would qualify for the study. Then one of the investigators would approach the patients and explain the study in detail. Patients would be able to give informed consent or refuse to participate.
Patients refusing to participate in the study will need to sign a consent that data will be collect for internal quality control (IRB approval on file). The patients would be scheduled for bariatric surgery and be treated per our current clinical practice.
All patients would undergo a similar anesthetic. At the end of the procedure, before the NMBA reversal agent is given, the patients would be randomized to either the control or study group.
Intraoperative Anesthestic Management:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.
排除标准
- •Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded.
研究组 & 干预措施
Study Group
quantitative monitoring of neuromuscular paralysis as described in (Brull Murphy Anesth Analg 2010;111:129-40) Acceleromyography
干预措施: Neostigmine (Drug)
Control Group
qualitative monitoring of neuromuscular paralysis, standard treatment at this facility
干预措施: Neostigmine (Drug)
Control Group
qualitative monitoring of neuromuscular paralysis, standard treatment at this facility
干预措施: Qualitative Monitor (Device)
Study Group
quantitative monitoring of neuromuscular paralysis as described in (Brull Murphy Anesth Analg 2010;111:129-40) Acceleromyography
干预措施: Accelomyography (Device)
结局指标
主要结局
Respiratory Events (RE)
时间窗: 2 years
Definition of RE, adapted from Ziemann-Gimmel et. al. f1000research 2012 and Murphy et. al. Anesth Analg 2010;107(1):130-7 Upper airway obstruction requiring an intervention; Hypoxemia despite 3 l/min NC requiring any intervention increasing FiO2 greater than 3 l/min NC tactile stimulation Signs of respiratory distress or impending ventilatory failure; Patient complaining of symptoms of respiratory or upper airway muscle weakness; w or w/o intervention Patient requiring reintubation in the PACU diagnosis of pneumonia on discharge or administration of antibiotics for suspected aspiration pneumonia unplaned application of CPAP/BiPAP unplanned ICU admission for respiratory reasons hypercarbic respiratory failure bag mask ventilation administration of "rescue" reversal after extubation for clinically suspected weakness prolonged intubation and ventilation in PACU and/or in ICU unplanned administration of breathing treatment
次要结局
未报告次要终点
研究者
Patrick Ziemann-Gimmel
MD, Anesthesiologist, Principal Investigator
Coastal Anesthesiology Consultants