Postoperative Pulmonary Complications (PPCs)NCT06862076
Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications
A study testing Lung Function Prehabilitation in people with Postoperative Pulmonary Complications (PPCs), run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Lung Function Prehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2023to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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
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.
- Being tested
- Lung Function Prehabilitation
- Keywords
- Prehabilitation, Postoperative pulmonary complications, Upper abdominal surgery, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Function PrehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lung Function Prehabilitation |
| Standard of Care | No intervention | No prehabilitation is done, patients in this group received standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
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.
Measured: Postoperative day 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Aug 2023
- Primary completion30 Jun 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862076
- Sponsor's protocol ID
- IndonesiaUAnes049
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06862076
- Acronym / sponsor ID
- IndonesiaUAnes049
- Keywords
- Prehabilitation, Postoperative pulmonary complications, Upper abdominal surgery, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Function Prehabilitation | Experimental | Procedure: Lung Function PrehabilitationParticipants 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. |
| Standard of Care | No intervention | –No prehabilitation is done, patients in this group received standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Function PrehabilitationParticipants 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. | Procedure or surgery | Lung Function Prehabilitation |
Primary outcome
Postoperative pulmonary complications
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pulmonary Complications (PPCs)
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Not yet recruitingObservational study
Physical Function Before Surgery and Lung Complications After Lung Surgery
Postoperative Pulmonary Complications (PPCs), Preoperative Functional Status
Enrolling by invitation
Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
Postoperative Pulmonary Complications (PPCs), Atelectasis
Recruiting
Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery
CABG, Respiratory Insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Function Prehabilitation in people with Postoperative Pulmonary Complications (PPCs), run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: Postoperative day 1 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.