NCT06044402尚未招募不适用
Effect of Intraoperative Low Tidal Volume vs Intermediate Tidal Volume on Oxygenation, Respiratory Mechanics, and Pulmonary Complications in Older Patients Undergoing Trendelenburg Pneumoperitoneum Surgery: A Randomized Clinical Trial
dong zhang0 个研究点目标入组 130 人开始时间: 2023年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 主要终点
- hypoxemia
研究概览
简要总结
The investigators want to assess the effect of intraoperative low tidal volume vs intermediate tidal volume on respiratory mechanics, oxygenation and pulmonary complications in older patients undergoing Trendelenburg pneumoperitoneum surgery.
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
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III class;
- •Colorectal cancer patients;
- •Elective laparoscopic colorectal surgery;
- •expected duration of surgery greater than 2 hours.
排除标准
- •serious complications associated with other systems;
- •severe cardiac insufficiency;
- •renal failure;
- •body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2;
- •the use of low tidal volume and consequent hypercapnia can induce harm;
- •refusal to participate in the study.
结局指标
主要结局
hypoxemia
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pneumonia
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
bronchospasm
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
atelectasis
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pulmonary congestion
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
respiratory failure
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
pleural effusion
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
PaO2/FiO2
时间窗: the lowest value at one hour after extubation, day-1 to day-3
the outcome in mmHg
pneumothorax
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
unplanned requirement for postoperative invasive or noninvasive ventilation
时间窗: From date of patient admission until the date of discharge, assessed up to 7 days
the outcome in fraction
次要结局
- Tidal volume(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- respiratory rate(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- dead space fraction(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- intrapulmonary shunt(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- peak airway pressure(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- mean airway pressure(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- A-aDO2(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- plateau airway pressure(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- dynamic compliance(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3))
- arterial blood Hct(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood SO2(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood K(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood Na(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood Lac(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood SBE(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- PaO2/FiO2(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- unplanned intensive care unit admission(From date of finishing surgery until the date of patient discharge, assessed up to 7 days)
- arterial blood Hb(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood Cl(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood PO2(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood PCO2(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood Ca(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood tBil(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- intensive care unit length of stay(From date of finishing surgery until the date of patient discharge, assessed up to 7 days)
- postoperative mortality(From date of finishing surgery until the date of patient discharge, assessed up to 7 days)
- arterial blood pH(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood ABE(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- arterial blood Glu(before anesthesia induction (T1); 60 minutes after initiation of the Trendelenburg position and CO2 pneumoperitoneum (T2), and 10 minutes after desufflation and resuming the supine position (T3).)
- hospital length of stay(From date of patient admission until the date of discharge, assessed up to 10 days)
研究者
dong zhang
Principal Investigator
Gansu Provincial Hospital
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