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

NCT05795608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-04-05

No results posted yet for this study

Summary

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

Conditions

  • Incentive Spirometry
  • Postoperative Pulmonary Complication
  • Major Abdominal Surgery

Interventions

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

Sponsors & Collaborators

  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2015-08-10
Completion
2015-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795608 on ClinicalTrials.gov