Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery

April 3, 2023 updated by: Ridho Ardhi Syaiful, Dr Cipto Mangunkusumo General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Measures In the intervention group, pulmonary function (vital capacity [VC], vital functional capacity [VFC], and Forced expiratory volume in the first second [FEV1]) were measured three times: two times before surgery (first day before undergoing the incentive spirometry procedure and second day after using the incentive spirometry) and one time after surgery. The control group measured pulmonary function three times: two times before surgery (on the first day of admission, on the day before surgery) and one time after surgery. In addition, postoperative pulmonary function was measured up to seven days following abdominal surgery, depending on the patient's ability.

On the first day after surgery, all subjects were examined by a pulmonologist, supplemented with a chest x-ray and blood gas analysis to assess the occurrence of postoperative pulmonary complications. PPC in this study included atelectasis (lung volume diminishing, caused by inadequate expansion of air cavity within lung parenchyma), pneumonia (all kinds of lung infection), and hypoxemia (ratio of PaO2: FiO2 less than 300).

The researchers used means (standard deviation, SD) and numbers (percentage,%) to describe the baseline subjects demographic and clinical characteristics. Henceforth, The researchers compared the change in lung function before and after surgery between intervention and control groups. An unpaired T-test was conducted to determine if the data were normally distributed. Alternatively, the Mann-Whitney test was done for abnormally distributed data. The researchers analyzed the comparison of lung complication incidence between experimental and control groups using chi-square or Fisher's exact test method. In this study, The researchers investigated the lung function of the experimental group before and after the incentive spirometry procedure.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
The intervention group received respiratory exercise with incentive spirometry before surgery
Device: respiratory exercise with incentive spirometry
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, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration
No Intervention: control group
The control group were given standard preoperative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with atelectasis
Time Frame: 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
day 1 until day 7
number of participants with pneumonia
Time Frame: 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
day 1 until day 7
number of participants with hypoxaemia
Time Frame: day 1 until day 7
Hypoxaemia was defined as PaO2/FiO2 <300 as assessed by blood gas analysis
day 1 until day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital capacity
Time Frame: Preoperative, day 1 before surgery, and until day 7 after surgery
It is the total amount of air exhaled after maximal inhalation
Preoperative, day 1 before surgery, and until day 7 after surgery
forced vital capacity
Time Frame: Preoperative, day 1 before surgery, and until day 7 after surgery
the maximum amount of air you can forcibly exhale from your lungs after fully inhaling
Preoperative, day 1 before surgery, and until day 7 after surgery
Forced expiratory volume in the first second
Time Frame: Preoperative, day 1 before surgery, and until day 7 after surgery
the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
Preoperative, day 1 before surgery, and until day 7 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

August 10, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSyaiful

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data in this study cannot be shared because the research database is no longer available due to damage to the hard disk where the data is stored.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Abdominal Surgery

Clinical Trials on respiratory exercise with incentive spirometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe