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临床试验/NCT02912819
NCT02912819已完成不适用

Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients

Fundación para la Investigación del Hospital Clínico de Valencia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
open-lung condition

研究概览

简要总结

General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized patients.

Investigators hypothesized that the SpO2 breathing air can personalize the open-lung approach.

详细描述

Increase in airway pressure until the SpO2 reaches 97% (lung´s opening pressure) during the incremental positive end-expiratory (PEEP) limb. Decrease in the PEEP level until the SpO2 decreases bellow 97% (lung´s closing pressure)

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Non-obese patients with ASA physical status I-III undergoing elective abdominal laparoscopic surgery with an expected operating time of less than 2 hours were included.

排除标准

  • age of <18 years,
  • preoperative SpO2 ≤97% while breathing room air, and
  • patients with previous known cardiac or respiratory disease.

结局指标

主要结局

open-lung condition

时间窗: During the experimental protocol (Intraoperative)

The role of the SpO2 to detect lung´s closing and opening pressures was evaluated by the discrete receiver operating characteristic (ROC) analysis. With PtpEE and PaO2/FIO2 as the reference methods, a binary classification of "1" to the open-lung condition defined as positive PtpEE or PaO2/FIO2 \>400 mmHg and "0" presence of lung collapse defined as negative PtpEE or PaO2/FIO2 \<400 mmHg. Also, a value of "1" was assigned when the SpO2 was ≥ 97% and a value of "0" when the value was \< 97%.

次要结局

未报告次要终点

研究者

发起方
Fundación para la Investigación del Hospital Clínico de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Ferrando

MD, PhD

Fundación para la Investigación del Hospital Clínico de Valencia

研究点 (1)

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