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临床试验/NCT03351946
NCT03351946已完成不适用

Zero Positive End-expiratory Pressure Applied Before Emergence Preoxygenation Prevents Postoperative Atelectasis - a Randomized Controlled Trial.

Region Västmanland1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in atelectasis area

研究概览

简要总结

A study on healthy patients undergoing anesthesia for non-abdominal surgery - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure on the amount of atelectasis 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 has been 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 prevent postoperative atelectasis formation.

This randomized controlled study will study patients undergoing non-abdominal day case surgeries under general anesthesia. The patients in the two study groups will receive mechanical ventilation with identical settings, comprising low TV, moderate PEEP, and no RM. At the end of surgery, the lungs will be examined by CT, and any atelectasis areas will be calculated. Randomization will occur after the first CT. 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. The study subjects will be examined with CT no.2 approximately thirty min after extubation. Primary endpoint measure will be atelectasis area as a percentage of total lung area. Blood gases will be collected for comparison of oxygenation as a secondary outcome measure.

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
Double (Participant, Outcomes Assessor)

盲法说明

Sealed envelopes.

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) class I-II
  • Non-abdominal day case surgery under general anesthesia

排除标准

  • Body mass index (BMI) ≥30 kg/m2
  • Arterial oxygen saturation (SpO2) breathing air <95 %
  • Chronic Obstructive Pulmonary Disease (COPD) or symptomatic asthma
  • Symptomatic congestive heart failure
  • Ischemic heart disease
  • Hemoglobin <100 g/L
  • Active smokers
  • Active smokers and ex-smokers with a history of more than 6 pack years.
  • Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

研究组 & 干预措施

ZEEP at awakening

Active Comparator

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) until start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan and immediately before start of emergence preoxygenation, this group will have the PEEP exchanged for zero PEEP (ZEEP). ZEEP will remain until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

干预措施: ZEEP (Procedure)

PEEP at awakening

Active Comparator

Controlled ventilation with tidal volume of 7 mL/kg of ideal body weight and respiratory frequency 10. Fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure (PEEP) is set to 7 or 9 cm H20 (9 if BMI≥25) even after start of emergence preoxygenation.

Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.

First CT scan after completion of surgery, before emergence. After the first CT scan, this group will have PEEP remained until the study subjects are extubated. Second CT scan approx. 30 min after extubation.

干预措施: PEEP (Procedure)

结局指标

主要结局

Change in atelectasis area

时间窗: Within 3 hours from induction of anesthesia. First CT after surgery, before emergence. Second CT approx 25 min after extubation. Study complete after that, no further CT.

Atelectasis area as studied by computed tomography.

次要结局

  • Change in oxygenation(Within 3 hours from induction of anesthesia. First blood gas after surgery, before emergence. Second approx 25 min after extubation. Study complete after that, no further blood gases.)

研究者

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

Erland Ostberg

Principal Investigator

Region Västmanland

研究点 (1)

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