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临床试验/NCT06862076
NCT06862076已完成不适用

The Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications on Patient Undergoing Upper Abdominal Surgery Treated in Intensive Care Unit: A Randomized Controlled Trial

Indonesia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月1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
40
试验地点
1
主要终点
Postoperative pulmonary complications

研究概览

简要总结

The aim of this study is to compare the effect of lung function prehabilitation to postoperative pulmonary complications on patient undergoing upper abdominal surgery treated in intensive care unit.

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
None

入排标准

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

入选标准

  • •adults 18 years or older
  • •scheduled for the upper abdominal surgery under general anesthesia with intraoperative mechanical ventilation
  • •possess adequate cognitive function to comprehend and follow instructions
  • •possess sufficient physical capacity to perform structured prehabilitation exercises
  • •express willingness to participate in the intervention program before surgery

排除标准

  • •pregnancy
  • •pre-existing severe pulmonary diseases such as chronic obstructive pulmonary disease (COPD)
  • •planned laparoscopic procedures
  • •history of significant neuromuscular impairment (e.g: stroke)
  • •declined to participate

研究组 & 干预措施

Lung Function Prehabilitation

Experimental

Participants assigned to the prehabilitation group received personalized exercise prescriptions, including aerobic training, muscle strengthening, and inspiratory muscle training with a threshold device. The prehabilitation program was conducted at the participants' homes for a minimum duration of two weeks. Adherence was monitored through logbook entries and video call evaluations to ensure correct implementation of the prescribed exercises.

干预措施: Lung Function Prehabilitation (Procedure)

Standard of Care

No Intervention

No prehabilitation is done, patients in this group received standard of care.

结局指标

主要结局

Postoperative pulmonary complications

时间窗: Postoperative day 1 and 3

Including pulmonary infections, atelectasis, and diaphragmatic dysfunction. Pulmonary infection is assessed using the Clinical Pulmonary Infection Score (CPIS) and with a threshold of \>6, atelectasis using Lung Ultrasound Score (LUS) of ≥1, and diaphragm ultrasound were used to evaluate diaphragm ratio. CPIS and LUS score assessments were conducted on postoperative day 1 and 3 by trained investigators, diaphragm ratio assessment was conducted preoperatively and on postoperative day 1 and 3, all findings were systematically recorded.

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

Dita Aditianingsih

Prof. Dr. dr. Dita Aditianingsih, Sp.An-TI., Subsp.T.I.(K).

Indonesia University

研究点 (1)

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