Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ΔEELV between baseline and after extubation before leaving the operating room.
研究概览
简要总结
The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.
详细描述
The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.
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
- Single (Participant)
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 undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure
排除标准
- •Known pregnancy
- •Pre-existing intubation or tracheostomy
- •Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery
- •Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)
研究组 & 干预措施
Control
A guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis.
Intervention
A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings.
干预措施: Low Intensity Mechanical Ventilation (Device)
结局指标
主要结局
ΔEELV between baseline and after extubation before leaving the operating room.
时间窗: Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).
Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room.
次要结局
- Proportion of patients with postoperative pulmonary complications at day 7(This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery)
- Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation)
- Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation)
- Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation)
- Change in estimated pulmonary artery systolic pressure (PASP, mmHg) from pre-intubation baseline to first post-extubation echocardiogram(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation)
- Recruitment rate(Day 0)
- Intervention deliverability(From intubation to extubation at Day 0)
- GI(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission)
- EELV(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission)
- COV(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission)
- RVDI(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission)
- Dorsal ROI(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission)
- EEPL(Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation)
- EIPL(Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation)
- Relationship between body mass index with optimal PEEP(Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery)
- Relationship of the degree of Trendelenburg inclination with optimal PEEP(Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery)
- Intraoperative oxygenation(Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation)
- Relationship of the pneumoperitoneum (insufflation) with optimal PEEP(Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery)
- Postoperative oxygenation(Postoperative Day 0: after PACU admission and 60min after PACU admission)
研究者
Maximilian S Schaefer
Associate Professor of Anesthesia
Beth Israel Deaconess Medical Center