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临床试验/NCT04150276
NCT04150276已完成不适用

Zero Positive End-expiratory Pressure Before Emergence Improves Postoperative Oxygenation in Obese Patients Undergoing Laparoscopic Surgery - a Randomized Clinical Trial

Region Västmanland1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in oxygenation

研究概览

简要总结

A study on overweight patients undergoing anesthesia for laparoscopic surgery.

  • evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.

详细描述

Positive end-expiratory pressure (PEEP) is often used during mechanical ventilation to preserve end-expiratory lung volume. After emergence and extubation, this volume will diminish instantly. Some patients will have difficulties to restore functional residual capacity (FRC) during the early phase of recovery. If routine high FIO2 is being delivered together with maintained PEEP prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. The investigators hypothesize that establishing zero positive end-expiratory pressure (ZEEP) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve oxygenation.

This randomized controlled study will study overweight patients undergoing general anesthesia for laparoscopic surgery. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, PEEP, and no RM. Randomization will occur at the end of surgery, before awakening. The patients will be allocated to zero PEEP (ZEEP) or maintained PEEP during emergence preoxygenation and extubation. Importantly, the intervention group will have ZEEP established while still having low ETO2 levels, prior to any preoxygenation. Arterial blood gases will be collected before, during and after anaesthesia. Primary endpoint measure will be change in oxygenation from before awakening to after awakening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Obese patients scheduled for elective laparocopic surgery.
  • American Society of Anesthesiologists functional class I-III
  • Body Mass Index 35-50 kg/m2

排除标准

  • Body Mass Index ≥50 kg/m2
  • Peripheral oxygen saturation (SpO2) breathing air <94 %
  • Symtomatic asthma, COPD or heart failure
  • Ischemic heart disease
  • Hemoglobin < 100g/l
  • Smokers and ex-smokers that stopped smoking < 9 months ago
  • Need for peroperative RM and PEEP higher than in study protocol, as indicated by SpO2 <92% despite the stipulated FiO2 0.30-0.
  • Obstructive sleep apnea syndrome on home-CPAP

结局指标

主要结局

Change in oxygenation

时间窗: Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.

Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.

次要结局

  • Need for postoperative supplemental oxygen(First 3 hours postoperatively.)

研究者

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

Erland Ostberg

Consultant, principal investigator

Region Västmanland

研究点 (1)

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