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临床试验/NCT04192305
NCT04192305Unknown不适用

Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
postoperative oxygen saturation

研究概览

简要总结

Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).

详细描述

The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse.

Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative.

LPV means:

tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)

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

  • bariatric surgery
  • morbid obesity ( BMI > 35)

排除标准

  • patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.

结局指标

主要结局

postoperative oxygen saturation

时间窗: up to maximum 4 hours

saturation is continuously measured in the post anesthetic area without giving oxygen until sat drops below 94%.

次要结局

未报告次要终点

研究者

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

Jan Mulier

MD PhD

AZ Sint-Jan AV

研究点 (1)

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