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CABGNCT06317363

Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients

A study testing Base Line + ACEPELLA and Base Line + Manual Chest Physiotherapy in people with CABG, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Read more about this study

Who is it for?
Ages 55 to 70 years
Conditions the study is for
CABG
What is being tested?
Base Line + ACEPELLA and Base Line + Manual Chest Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
23 May 2023to 15 Feb 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 55 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • both gender
  • Patients aged between 55-70 years
  • Vitally Stable
  • extubated post-CABG day 01 patients
  • Patient undergone for the 1st time CABG

Who cannot join

  • With a history of chronic obstructive pulmonary disease or asthma patient
  • Intubated patient
  • Surgical complication after CABG
  • With a history of smoking
  • Patients who have undergone thoracic surgery in the past
  • Patients with a history of neuromuscular disorders
  • Patients with a history of heart failure
  • Vitally unstable or on ventilator post CABG patients

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Jinnah Hospital

    Lahore, Punjab Province, 54600

Other trials in Pakistan

About this study

Official title: Effects of Acapella VS Chest Physiotherapy on Dyspnea, Pulmonary Functions and Air Way Clearance in Post-Operative CABG Patients

Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.

The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.

The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study

Conditions
CABG
Being tested
Base Line + ACEPELLA, Base Line + Manual Chest Physiotherapy
Keywords
Cardiac surgery, CABG, Pulmonary function, Airway clearance, Dyspnea, post-operative complications, Pneumonia, Atelectasis
Medical subject headings
Dyspnea, Pneumonia, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Base Line + ACEPELLAOther

    Group A (baseline treatment + acapella) consisting of 15 participants will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella). The primary and secondary outcome measures will be assessed at baseline post-op day 1, and after 1 week of surgery.

  • Base Line + Manual Chest PhysiotherapyOther

    The group B consisting of 15 participants will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute. The s primary and secondary outcome measures will be assessed at baseline post-op day 1, and after 1 week of surgery.

Study groups in NCT06317363
Study groupRoleWhat they receive
Experimental Group A (ACAPELLA)ExperimentalGroup A (baseline treatment + acapella)
Receives: Other: Base Line + ACEPELLA
Experimental Group B (MANUAL CHEST PHYSIOTHERAPY)ExperimentalGroup B (baseline + manual chest physiotherapy)
Receives: Other: Base Line + Manual Chest Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Borg Dyspnea Scale

    It is a subjective tool to assess degree of dyspnea in patients. The comprise of 10 grades starting from zero to 10. Zero refers to 'No difficulty in breathing at all 'and 10 refers to 'maximal difficulty ' Readings will be taken at 1st post op day and after post op week 1

    Measured: 1 week

  2. FEV1

    digital spirometer device will be used to take readings of lung volumes in (ml). These measurements are part of a pulmonary function test, which helps diagnose and monitor respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Readings will be taken at 1st post op day and after 1st post op week

    Measured: 1 week

  3. FVC

    digital spirometer device will be used to take readings of lung capacities in (ml). These measurements are part of a pulmonary function test, which helps diagnose and monitor respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. Readings will be taken at 1st post op day and after 1st post op week

    Measured: 1 week

  4. FEV1/FVC

    digital spirometer device will be used to take readings of FEV1/FVC. Readings will be taken at 1st post op day and after 1st post op week

    Measured: 1 week

  5. sputum volume

    A sputum collection jar will be used to record the amount of sputum produced by a patient over a specific period of time in (ml). Sputum is a mixture of saliva and mucus that is expectorated from the lungs. By tracking the amount and consistency of sputum, healthcare professionals can monitor the progression of respiratory conditions and assess the effectiveness of treatment.

    The readings of these outcome measure will be taken two times. 1st post op day and after 1st week

    Measured: 1 Weeks

Secondary outcomes (8)

  1. body temperature(degree centigrade)

    Pre-post readings of vitals will be taken from monitor attached to the patient

    Measured: 1 week

  2. pulse rate (beats/minute)

    Pre-post readings of vitals will be taken from monitor attached to the patient

    Measured: 1 week

  3. respiratory rate( breaths/minute)

    Pre-post readings of vitals will be taken from monitor attached to the patient

    Measured: 1 week

  4. blood pressure (mmHg)

    Pre-post readings of vitals will be taken from monitor attached to the patient

    Measured: 1 week

  5. SpO2 (%)

    pre-post readings will be taken of oxygenic indicators through ABGs

    Measured: 1 week

  6. SaO2 (%)

    pre-post readings will be taken of oxygenic indicators through ABGs

    Measured: 1 week

  7. PaO2 (%)

    pre-post readings will be taken of oxygenic indicators through ABGs

    Measured: 1 week

  8. PaCO2 (%)

    pre-post readings will be taken of oxygenic indicators through ABGs

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start23 May 2023
  3. Primary completion30 Jan 2024
  4. Study completion15 Feb 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06317363
Sponsor's protocol ID
REC/RCR&AHS/23/0353
Status last verified
Mar 2024
First submitted
4 Mar 2024
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Farina P, Gaudino MFL, Taggart DP. The Eternal Debate With a Consistent Answer: CABG vs PCI. Semin Thorac Cardiovasc Surg. 2020 Spring;32(1):14-20. doi: 10.1053/j.semtcvs.2019.08.009. Epub 2019 Aug 20.

    PubMed 31442489

  • Jannati M, Navaei MR, Ronizi LG. A comparative review of the outcomes of using arterial versus venous conduits in coronary artery bypass graft (CABG). J Family Med Prim Care. 2019 Sep 30;8(9):2768-2773. doi: 10.4103/jfmpc.jfmpc_367_19. eCollection 2019 Sep.

    PubMed 31681641

  • Shawon MSR, Odutola M, Falster MO, Jorm LR. Patient and hospital factors associated with 30-day readmissions after coronary artery bypass graft (CABG) surgery: a systematic review and meta-analysis. J Cardiothorac Surg. 2021 Jun 10;16(1):172. doi: 10.1186/s13019-021-01556-1.

    PubMed 34112216

  • Yamamoto K, Natsuaki M, Morimoto T, Shiomi H, Matsumura-Nakano Y, Nakatsuma K, Watanabe H, Yamamoto E, Kato E, Fuki M, Yamaji K, Nishikawa R, Nagao K, Takeji Y, Watanabe H, Tazaki J, Watanabe S, Saito N, Yamazaki K, Soga Y, Komiya T, Ando K, Minatoya K, Furukawa Y, Nakagawa Y, Kadota K, Kimura T; CREDO-Kyoto PCI/CABG Registry Cohort-3 investigators. Periprocedural Stroke After Coronary Revascularization (from the CREDO-Kyoto PCI/CABG Registry Cohort-3). Am J Cardiol. 2021 Mar 1;142:35-43. doi: 10.1016/j.amjcard.2020.11.031. Epub 2020 Dec 3.

    PubMed 33279479

  • Rupprecht L, Schmid C, Debl K, Lunz D, Florchinger B, Keyser A. Impact of coronary angiography early after CABG for suspected postoperative myocardial ischemia. J Cardiothorac Surg. 2019 Mar 12;14(1):54. doi: 10.1186/s13019-019-0876-0.

    PubMed 30871615

  • Moradian ST, Heydari AA, Mahmoudi H. What is the Role of Preoperative Breathing Exercises in Reducing Postoperative Atelectasis after CABG? Rev Recent Clin Trials. 2019;14(4):275-279. doi: 10.2174/1574887114666190710165951.

    PubMed 31291879

  • Chen X, Li C, Zeng L, Rong T, Lin P, Wang Q, Guo Z, Long H, Zhong J. Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial. BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.

    PubMed 36978035

Questions about this trial

What is this clinical trial studying?

A study testing Base Line + ACEPELLA and Base Line + Manual Chest Physiotherapy in people with CABG, run by Riphah International University at 1 site 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 5 inclusion and 8 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 19 Mar 2024. 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 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?

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?

Modified Borg Dyspnea Scale (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06317363, which also lists 7 linked publications.

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 19 Mar 2024.

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