Major Abdominal Surgery Clinical Trial
Official title:
Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery In Indonesia Three Major Tertiary Hospitals: A Randomized Controlled Trial
NCT number | NCT05795608 |
Other study ID # | RSyaiful |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2015 |
Est. completion date | September 1, 2015 |
Verified date | April 2023 |
Source | Dr Cipto Mangunkusumo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 46 |
Est. completion date | September 1, 2015 |
Est. primary completion date | August 10, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Dr Cipto Mangunkusumo General Hospital |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of participants with atelectasis | 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 | |
Primary | number of participants with pneumonia | 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 | |
Primary | number of participants with hypoxaemia | Hypoxaemia was defined as PaO2/FiO2 <300 as assessed by blood gas analysis | day 1 until day 7 | |
Secondary | vital capacity | It is the total amount of air exhaled after maximal inhalation | Preoperative, day 1 before surgery, and until day 7 after surgery | |
Secondary | forced vital capacity | 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 | |
Secondary | Forced expiratory volume in the first second | 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 |
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