Surgery-ComplicationsNCT06378073
Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery
A study testing Incentive Spirometer and Numeric Pain Rating Scale in people with Surgery-Complications, run by Superior University at 5 sites in Pakistan.
Trial summary
"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. Read more about this study
- Who is it for?
- Ages 48 to 88 years
- Conditions the study is for
- Surgery-Complications
- What is being tested?
- Incentive Spirometer and Numeric Pain Rating Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 5 sitesPakistan
- Study dates
- 5 Apr 2024to 1 Sep 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 48 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing in Cardiac Surgery like, CABG, univalve, bivalve and trivalve.
Who cannot join
- Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
- Cognitive disorder of the heart.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Pakistan5 sites
Azra Naheed Medical College, Superior University
Lahore, Punjab Province
Bahria Hospital
Lahore, Punjab Province
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
The University of Lahore Teaching Hospital
Lahore, Punjab Province
Punjab Institute of Cardiology Hospital
Lahore
About this study
Official title: Effects of Chest Physiotherapy Exercise in Prevention of Pre-Operative and Post-Operative Complications Followed By Cardiac Surgery
"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.
In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"
- Conditions
- Surgery-Complications
- Being tested
- Incentive Spirometer, Numeric Pain Rating Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometerDiagnostic test
Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications. (1) Validity and reliability: Incentive spirometry can be used as a simple mean to follow lung function, especially VC, in the postoperative period in spontaneously breathing patients. Incentive spirometry is noninvasive and can be performed repeatedly at the bedside in the intensive care setting. (2)
Interpretation:
There are only three numeric values that are required to interpret spirometry:
- Forced Vital Capacity (FVC)
- Forced Expiratory Volume (FEV1)
- FEV1/FVC ratio.
Numeric Pain Rating ScaleDiagnostic test
Sensitivity: The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76, indicating fair accuracy. A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) he diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments. (3)
Measurement (circle): Categorical /Numerical /Both:
Numerical:
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometer | Experimental | Not described Receives: Diagnostic Test: Incentive Spirometer |
| Numeric Pain Rating Scale | Other | Not described Receives: Diagnostic Test: Numeric Pain Rating Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incentive Spirometer
A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) Specificity: The diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments.
Measured: 6 Month
Incentive Spirometer
Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start5 Apr 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378073
- Sponsor's protocol ID
- DPT/Batch-Fall19/557
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chest Physiotherapy Exercise in Prevention of Pre-Operative and Post-Operative Complications Followed By Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06378073
- Acronym / sponsor ID
- DPT/Batch-Fall19/557
- Conditions
- Surgery-Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.
In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometer | Experimental | Diagnostic Test: Incentive Spirometer |
| Numeric Pain Rating Scale | Other | Diagnostic Test: Numeric Pain Rating Scale |
Who may qualify
- Ages
- 48 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing in Cardiac Surgery like, CABG, univalve, bivalve and trivalve.
Key exclusion criteria (2 listed)
- Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
- Cognitive disorder of the heart.
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 |
|---|---|---|
| Incentive SpirometerSpecificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications. (1) Validity and reliability: Incentive spirometry can be used as a simple mean to follow lung function, especially VC, in the postoperative period in spontaneously breathing patients. Incentive spirometry is noninvasive and can be performed repeatedly at the bedside in the intensive care setting. (2) Interpretation: There are only three numeric values that are required to interpret spirometry: * Forced Vital Capacity (FVC) * Forced Expiratory Volume (FEV1) * FEV1/FVC ratio. | Diagnostic test | Incentive Spirometer |
| Numeric Pain Rating ScaleSensitivity: The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76, indicating fair accuracy. A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) he diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments. (3) Measurement (circle): Categorical /Numerical /Both: Numerical: The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Diagnostic test | Numeric Pain Rating Scale |
Primary outcome
Incentive Spirometer
Time frame: 6 Month
A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) Specificity: The diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS > 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS > 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments.
Incentive Spirometer
Time frame: 6 Months
Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometer and Numeric Pain Rating Scale in people with Surgery-Complications, run by Superior University at 5 sites in Pakistan.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Pakistan. 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?
Results are not available in the source record.
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?
Incentive Spirometer (time frame: 6 Month). The study lists 2 primary outcomes in all. 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 22 Apr 2024.