PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After ROBOT-Assisted Laparoscopic Surgery - an International Multicenter Pilot Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Safety of intraoperative FCV
研究概览
简要总结
The investigators want to investigate in patients undergoing robot-assisted laparoscopic surgery (a minimally invasive procedure) how applicable flow-controlled ventilation is, and whether it might also be safer than the current ventilation techniques, as well as its impact on potentially reducing the risk of lung-specific complications.
Flow-controlled ventilation has already been tested in several studies on animals and humans and has proven to be a safe form of ventilation for patients undergoing surgery under general anesthesia.
When patients undergo major surgery, general anesthesia is required and, as a result, mechanical ventilation of the lungs. Especially in long and complex surgeries, ventilation can become more difficult or lead to complications postoperatively. These patients may then experience shortness of breath, coughing, or require medication to improve lung function. In some cases, reintubation or additional mechanical ventilation may be necessary for support.
Previous human studies have shown that flow-controlled ventilation is less stressful and, therefore, potentially safer for the lungs compared to traditional ventilation techniques, and that less supplemental oxygen is required. This effect and the safety of flow-controlled ventilation have been demonstrated in several studies.
Therefore, in this study, the investigators aim to explore whether flow-controlled ventilation is potentially safer and easier to apply than traditional ventilation techniques and whether it can reduce the risk of lung-specific complications following robot-assisted surgeries, thereby improving the recovery process postoperatively.
详细描述
The optimization of intraoperative ventilation is important in patients under general anesthesia, when physiologic breathing is replaced by non- physiologic artificial ventilation. Especially in patients undergoing robot- assisted laparoscopic surgery, intraoperative ventilation can be challenging, because of changes in compliance of the respiratory system and associated problems in gas exchange, due to the pneumoperitoneum and often extreme body positioning. Intraoperative lung-protection strategies have steadily improved in recent years to reduce complications from mechanical ventilation, but postoperative pulmonary complications remain a risk factor for increased morbidity and mortality. This pilot trial will be conducted to evaluate the safety and feasibility of intraoperative FCV during robot-assisted laparoscopic abdominal, urologic, or gynecologic surgery, and will inform the design of a future trial that will test the efficacy of intraoperative FCV compared to PCV in these patients. In an international multicenter randomized clinical pilot trial, intraoperative flow-controlled ventilation (FCV) will be compared with pressure-controlled ventilation (PCV) in patients scheduled for robot-assisted laparoscopic abdominal, urologic, or gynecologic surgery. This pilot trial is designed to test the safety and feasibility of FCV, and to inform the design of a future trial testing the efficacy of FCV with regard to postoperative outcomes, including postoperative pulmonary complications. The ventilation modes are conducted with CE-marked medical devices (anesthesia ventilators or medical ventilators), however these medical devices themselves are not under investigation. All CE-marked standard medical devices from varied manufacturers in use at the participating study centers will be used in full accordance with the instructions for use.
Given that ventilation strategies inherently carry certain risks, yet remain essential in the context of general anesthesia and surgery, it is ethically justified to first conduct a pilot trial. The potential benefits of FCV are significant and warrant investigation. Therefore, the investigators find it appropriate to compare FCV with existing strategies such as PCV, as the investigators anticipate meaningful improvements in patient outcomes with minimal additional risk.
The investigators hypothesize, that FCV is a safe and feasible ventilation strategy in patients undergoing robot-assisted laparoscopic surgery.
The primary objective of this study is to evaluate the safety of intraoperative FCV in patients undergoing robot-assisted laparoscopic surgery, with a focus on: gas exchange, including both oxygenation and decarboxylation; minute ventilation, during all phases of intraoperative ventilation; key ventilator settings and ventilation parameters; respiratory complications, including pneumothorax and hemodynamic complications, including hypotension and arrhythmias.
The secondary objectives are to assess the feasibility of intraoperative FCV and the study protocol in patients undergoing robot-assisted laparoscopic surgery, including an evaluation of the use of FCV. The need for rescue ventilation strategies, i.e., whether FCV (as well as PCV) can be used during all phases of intraoperative ventilation; and compliance with the study protocol, omissions in the eCRF, and the feasibility of follow-up, i.e., how well each PPC can be captured.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing elective robot-assisted laparoscopic surgery in supine or Trendelenburg position (either abdominal, urologic or gynecologic surgery);
- •AND increased risk of PPCs according to the ARISCAT risk score (≥ 26 points);
- •OR the combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery;
- •aged ≥ 18 years; and
- •able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention.
排除标准
- •ideal body weight < 40 kg;
- •ASA Physical Status Classification System score IV - VI;
- •previous enrolment into the current study;
- •being the study investigator, his/her family members, employees and other dependent persons;
- •if female and of childbearing potential, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; or
- •No informed consent
研究组 & 干预措施
Intraoperative flow-controlled ventilation FCV
Flow-controlled ventilation (FCV) differs from conventional ventilation modes in several key ways. Unlike pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV), FCV maintains a constant airflow during both the inspiration and expiration phases. This method generates smooth linear pressure variations by delivering a constant positive flow during inspiration and a constant negative flow during expiration, resulting in linearly changing airway pressures. Additionally, FCV operates without any interruptions in flow throughout the cycle. This consistent rate of pressure and volume change in the lungs, particularly the linear decrease in airway pressure during expiration, has been shown to improve lung recruitment. This approach may thus reduce the risk of pulmonary complications commonly associated with conventional ventilation modes.
干预措施: Intraoperative flow-controlled ventilation strategy (Other)
Intraoperative pressure-controlled ventilation PCV
Pressure-controlled ventilation (PCV) is the standard of care in patients undergoing mechanical ventilation during general anesthesia in robot-assisted laparoscopic surgery. The operator sets the inspiratory pressure (rather than tidal volume as in VCV) and respiratory rate (along with FiO2, I:E ratio and PEEP). Typically, the pressure is titrated to achieve a targeted tidal volume.
干预措施: Intraoperative pressure-controlled ventilation strategy (Other)
结局指标
主要结局
Safety of intraoperative FCV
时间窗: After induction of general anesthesia and beginning of intraoperative mechanical ventilation to the end of surgery and the end of mechanical ventilation (up to a duration of 12 hours of mechanical ventilation).
The primary objective of this pilot trial is to evaluate the safety of intraoperative FCV in patients undergoing robot-assisted laparoscopic surgery. Herein the investigators focus on, gas exchange, including both oxygenation and decarboxylation; minute ventilation, during all phases of intraoperative ventilation; key ventilator settings and ventilation parameters; respiratory complications, including pneumothorax and hemodynamic complications, including hypotension and arrhythmias.
次要结局
- feasibility of intraoperative FCV, study protocol and database completeness(After induction of general anesthesia and beginning of intraoperative mechanical ventilation to the seventh postoperative day or until end of hospitalization, whatever comes first (i.e., up to 7 days after surgery))
研究者
Dr. Timur Yurttas
MD
Cantonal Hospital of St. Gallen