Clinical trial NCT06317363: Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients
Official title: Effects of Acapella VS Chest Physiotherapy on Dyspnea, Pulmonary Functions and Air Way Clearance in Post-Operative CABG Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CABG
Keywords: Cardiac surgery
CABG
Pulmonary function
Airway clearance
Dyspnea
post-operative complications
Pneumonia
Atelectasis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Borg Dyspnea Scale
timeFrame: 1 week
measure: FEV1
timeFrame: 1 week
measure: FVC
timeFrame: 1 week
measure: FEV1/FVC
timeFrame: 1 week
measure: sputum volume
timeFrame: 1 Weeks
Secondary outcomes:
measure: body temperature(degree centigrade)
timeFrame: 1 week
measure: pulse rate (beats/minute)
timeFrame: 1 week
measure: respiratory rate( breaths/minute)
timeFrame: 1 week
measure: blood pressure (mmHg)
timeFrame: 1 week
measure: SpO2 (%)
timeFrame: 1 week
measure: SaO2 (%)
timeFrame: 1 week
measure: PaO2 (%)
timeFrame: 1 week
measure: PaCO2 (%)
timeFrame: 1 week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Muriam Ghani, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.