Comparison of preoperative segmental and diaphragmatic breathing exercise on functional mobility, length of hospital stay in on-pump versus off-pump coronary artery bypass graft patients.

To compare the effects of preoperative diaphragmatic and segmental breathing exercises on functional mobility, dyspnea and hospital length of stay in both on pump and off pump CABG.

Prospective randomized clinical study with two groups interventional and control group enrolled between October 2023 to April 2024, followed for 6 months. Sample size of 170 and each group will contain 85 patients. The surgeon will be blind to procedure until he opens the envelope in preoperative room. The participants will be blind to the procedure both pre and postoperatively. The data analyzer will be blind till final statistical results calculation.

Integrated Medical Care & National hospital and Medical Centre Lahore Pakistan. Participant Blinding Researcher/Healthcare Provider Blinding Data Analyst Blinding

Inclusion Criteria Both male and female patients within the age of 40 to 70 years based upon coronary angiography, left ventricle ejection fraction ≥35% determined by echocardiogram will be included. Exclusion Criteria Patients with unstable angina, preoperative lung complication, on steroids and bronchodilators, with endocrine abnormalities such as hyper or hypothyroidism, neurological disability and/or musculoskeletal disorder, concomitant valve disease.

Interventional group: Segmental & diaphragmatic breathing exercise is carried out on a lung segment with the aim of enhancing ventilation and oxygenation efficiency, promoting diaphragm movement. Control Group: Incentive spirometry helps to expand your lungs, strengthening your lungs and clearing mucus.

A Functional Mobility Scale (FMS) Dyspnea evaluation by using Modified medical research council dyspnea scale Pulmonary Complication evaluation by using Chest Xray Chest Expansion evaluation Dyspnea (D-12) Questionnaire

I mistakenly mentioned wrong expected start and end date of recruitment. Now, I corrected both dates please approve this trial by this change.

After allocation of patients by card allocation method into control and experimental groups through randomization in surgeon clinic by the surgeon. There will be one box and patients’ cards will be in sealed envelope with nothing written on envelope. Card will have patient hospital number and name. After completion of determined number of patients surgeon will pick half the number of envelope’s without opening the envelope and will designate to group A and the other equal half to group B. The baseline data will be taken that will include functional mobility scale for mobility assessment, Modified medical research council dyspnea scale for dyspnea, pulmonary complications by using chest Xray, chest expansion evaluation and Dyspnea (D-12) Questionnaire for shortness of breath. Then both groups will receive breathing exercises as per defined criteria for 3 weeks. After the completion of treatment at 3 weeks the data regarding functional mobility scale for mobility assessment, Modified medical research council dyspnea scale for dyspnea, pulmonary complications by using chest Xray, chest expansion evaluation and Dyspnea (D-12) Questionnaire for shortness of breath will be taken for both groups of patients. It will be a prospective randomized clinical study where surgeon will be blind from on-pump and off-pump surgical procedure until he will open the envelope in preoperative room. The patient will be blind to the procedure both pre and postoperatively. And data analyzer will also be blind till getting the statistical results of techniques in both groups.

Participant Blinding: The participants or patients undergoing the study would be kept unaware of certain key details. In this specific study, the patients might not be informed whether they are receiving "segmental" or "diaphragmatic" breathing exercises. They may also not know whether they are undergoing "on-pump" or "off-pump" coronary artery bypass graft surgery. This ensures that the patients' expectations and perceptions do not influence their responses or outcomes. Researcher/Healthcare Provider Blinding: The healthcare providers and researchers involved in the study would also be blinded to certain information. For example, the therapists or clinicians responsible for administering the breathing exercises should not be aware of whether they are providing "segmental" or "diaphragmatic" exercises to the patients. Similarly, the surgical team would not know whether they are performing an "on-pump" or "off-pump" procedure. Data Analyst Blinding: To maintain objectivity in data analysis, the individuals responsible for collecting and analyzing data would also be blinded to the treatment groups. In this case, the statisticians or data analysts should receive anonymized data without information about the specific treatment received by each patient. This prevents potential bias during the data analysis phase.

Comparison of preoperative segmental and diaphragmatic breathing exercise on functional mobility, length of hospital stay in on-pump versus off-pump coronary artery bypass graft patients

After collecting from patients

After data collection from patients

For study purpose only

From hospitals

A written informed consent from university hospital and patients will be taken.