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临床试验/NCT05702554
NCT05702554招募中不适用

Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study

Azienda Ospedaliera di Perugia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Intraoperative respiratory system mechanics

研究概览

简要总结

The present investigation is focused to assess the effects of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum

详细描述

Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.

Will be excluded all the patients with the following conditions: American society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheostomy, previous cardio-thoracic surgery, pulmonary hypertension, broncho-pleural fistula, pulmonary emphysema, pneumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.

Thereafter, general anesthesia will be induced, according to current clinical practice and mechanical ventilation will be commenced according to current recommendations.

Following the application of definitive pneumoeritoneum and body position, the recruitment/inflation procedure will be carried out to identify PEEP. PEEP-induced recruitment will be computed with high PEEP set at 15 cmh2o (or higher) and low PEEP set at 5 cmh2o. In case of an airway opening pressure > 5 cmh2o, the airway opening pressure (AOP) will be set as low PEEP and the high PEEP will be set at the value corresponding to AOP+ 10 cmh20. During the procedure, tidal volume will be maintained between 6-8 ml/kg of predicted body weight. On the basis of the recruitment-to-inflation ratio (R/I), PEEP will be set as follows: low PEEP, in presence of R/I < 0,5; high PEEP with R/I ≥ 1.5; PEEP set within low and high PEEP range on clinical decision, if R/I ≥ 0.5 and <1.5.

After 20 min from the onset of mechanical ventilation and 1 hour from PEEP application following pneumoperitoneum and definitive body position, mechanics of the respiratory system for compliance and driving pressure will be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent.

排除标准

  • Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.

结局指标

主要结局

Intraoperative respiratory system mechanics

时间窗: 1 hour following PEEP application

respiratory system compliance defined as volume variation to pressure variation ratio

次要结局

  • respiratory pulmonary complications incidence(up to 7 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Gianmaria Cammarota

Prof Gianmaria Cammarota

Azienda Ospedaliera di Perugia

研究点 (1)

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