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临床试验/NCT05795608
NCT05795608已完成不适用

Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery In Indonesia Three Major Tertiary Hospitals: A Randomized Controlled Trial

Dr Cipto Mangunkusumo General Hospital0 个研究点目标入组 46 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
主要终点
number of participants with hypoxaemia

研究概览

简要总结

This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery.

This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The investigators randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.

All study subjects were simple randomly allocated to the intervention and control groups according to the randomization table.

The hypothesis of the study team was that preoperative incentive spirometry can improve the incidence of postoperative pulmonary complications in major abdominal surgery

详细描述

This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The researchers randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.

The researchers included patients aged between 18 and 65 years old who underwent elective major abdominal surgery into random allocation. Patients were excluded if had a history of pulmonary disease and were unwilling or unable to take a deep breath effectively due to pain, diaphragmatic dysfunction, or opiate analgesia.

All study subjects were simple randomly allocated into the intervention and control groups according to the randomization table. The intervention group (23 subjects) received respiratory exercise with incentive spirometry before surgery, and the control group (23 subjects) were given standard preoperative care.

Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, The subjects were asked to inhale deeply and slowly, and were also directed to hold their breath at the end of inspiration.

With alpha of 5%, beta of 10%, 39% postoperative pulmonary complication rate, as mentioned in the previous study,13 and assumption of that incentive spirometry can reduce the PPC to 30%, this study required at least 23 subjects in each group to see the effectiveness of using incentive spirometry before surgery in preventing PPC.

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 (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing major abdominal surgery
  • aged between 18 and 65 years old
  • Sign research informed consent

排除标准

  • Emergency surgery
  • Have a history of lung disorders
  • Refusing to continue incentive spirometry
  • Patients who cannot follow instructions in using the device incentive spirometry.

结局指标

主要结局

number of participants with hypoxaemia

时间窗: day 1 until day 7

Hypoxaemia was defined as PaO2/FiO2 \<300 as assessed by blood gas analysis

number of participants with atelectasis

时间窗: day 1 until day 7

The loss of lung volume is caused by inadequate expansion of the air spaces lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist

number of participants with pneumonia

时间窗: day 1 until day 7

Any form of infection of the lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist

次要结局

  • vital capacity(Preoperative, day 1 before surgery, and until day 7 after surgery)
  • forced vital capacity(Preoperative, day 1 before surgery, and until day 7 after surgery)
  • Forced expiratory volume in the first second(Preoperative, day 1 before surgery, and until day 7 after surgery)

研究者

发起方
Dr Cipto Mangunkusumo General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ridho Ardhi Syaiful

Medical Doctor, Digestive Surgery

Dr Cipto Mangunkusumo General Hospital

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