Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,800
- 主要终点
- Occurrence of at least one postoperative pulmonary complication
研究概览
简要总结
SupAIR is an international, multicenter, randomized controlled trial investigating whether airway management and neuromuscular blockade during general anesthesia influence postoperative pulmonary complications.
Approximately 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms: tracheal intubation with moderate neuromuscular blockade, tracheal intubation with deep neuromuscular blockade, supraglottic airway with moderate neuromuscular blockade, supraglottic airway with deep neuromuscular blockade, or supraglottic airway without neuromuscular blockade.
The primary outcome is the occurrence of postoperative pulmonary complications during the hospital stay. Secondary outcomes include perioperative complications, surgical conditions, recovery, and functional health. Participants will be followed during hospitalization and again approximately six months after surgery.
详细描述
SupAIR is an international, multicenter, randomized, controlled, parallel-group clinical trial evaluating the effects of airway management and neuromuscular blockade (NMB) on postoperative pulmonary complications after general anesthesia.
A total of 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms:
- Tracheal tube with moderate NMB
- Tracheal tube with deep NMB
- Supraglottic airway device with moderate NMB
- Supraglottic airway device with deep NMB
- Supraglottic airway device without NMB
The five treatment arms result from an initial allocation to tracheal tube with NMB, supraglottic airway device with NMB, or supraglottic airway device without NMB. Participants assigned to NMB are additionally randomized to moderate or deep neuromuscular blockade.
The study addresses two primary hypotheses. First, among participants receiving NMB, use of a supraglottic airway device is hypothesized to reduce postoperative pulmonary complications compared with tracheal intubation. Second, among participants managed with a supraglottic airway device, the use of NMB is hypothesized not to increase postoperative pulmonary complications compared with no NMB. Finally, among participants receiving NMB depth of neuromuscular blockade will be used as secondary exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation. The intraoperative anaesthesia team and personnel responsible for intraoperative trial conduct will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years) with an ASA physical status ≤ 3 scheduled for elective non-cardiac surgery under general anaesthesia whose airway can be secured via tracheal tube or SGA.
排除标准
- •Contraindications for using supraglottic devices, tracheal tube, or neuromuscular blocking agents (and reversal drugs); surgery in prone positioning; surgical procedures scheduled outside the operating room; ambulatory surgery; pregnancy; patients planned for consecutive anaesthetic/surgical procedures in the following 14 days or within the past 14 days.
研究组 & 干预措施
Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)
General anesthesia with tracheal tube management and moderate neuromuscular blockade.
干预措施: Airway management strategy (Procedure)
Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)
General anesthesia with tracheal tube management and moderate neuromuscular blockade.
干预措施: Deep versus moderate neuromuscular blockade (NMB) (Other)
Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)
General anesthesia with supraglottic airway device management and deep neuromuscular blockade.
干预措施: Airway management strategy (Procedure)
Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)
General anesthesia with supraglottic airway device management and deep neuromuscular blockade.
干预措施: Initiation of neuromuscular blockade (NMB) (Procedure)
Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)
General anesthesia with supraglottic airway device management and deep neuromuscular blockade.
干预措施: Deep versus moderate neuromuscular blockade (NMB) (Other)
Supraglottic Airway Device without Neuromuscular Blockade (SGA/no NMB)
General anaesthesia with supraglottic airway device management without neuromuscular blockade.
干预措施: Initiation of neuromuscular blockade (NMB) (Procedure)
Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)
General anesthesia with tracheal tube management and deep neuromuscular blockade.
干预措施: Airway management strategy (Procedure)
Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)
General anesthesia with tracheal tube management and deep neuromuscular blockade.
干预措施: Deep versus moderate neuromuscular blockade (NMB) (Other)
Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)
General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.
干预措施: Airway management strategy (Procedure)
Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)
General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.
干预措施: Initiation of neuromuscular blockade (NMB) (Procedure)
Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)
General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.
干预措施: Deep versus moderate neuromuscular blockade (NMB) (Other)
结局指标
主要结局
Occurrence of at least one postoperative pulmonary complication
时间窗: Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier
The primary outcome is a composite endpoint of postoperative pulmonary complications. It is met if a participant experiences at least one predefined postoperative pulmonary complication and their severity is graded according to the Clavien-Dindo-Classification
次要结局
- Intraoperative complications(During the surgery)
- Critical respiratory events in the recovery room(During post-anesthesia care before admission to the normal ward)
- Any postoperative in-hospital complication(Patients are visited on postoperative days 1, 3, 5, 8, 15 and on the day of discharge from hospital or day 28 (whatever occurs first) to document complications between the current and the last visit.)
- Surgical conditions(During surgery, assessed every 15 minutes)
- Quality of Recovery questionnaire(On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180)
- Functional Health(On the day of admission and 180 days after surgery)
- Further Outcomes(Retrieved from Chart Review or at the 180 day follow-up)
研究者
Manfred Blobner
Principal Investigator, Professor of Anesthesiology and Intensive Care Medicine
University Hospital Ulm