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IRCT20230920059477N1 IRCT 2023-10-14 National Hospital and medical Centre lahore Punjab Effect of preoperative breathing exercises in coronary artery bypass graft patients 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. 2023-10-22 anticipated 170 Complete https://irct.ir/trial/72827 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 1-2 Coronary artery disease. Intervention 1: Intervention group: Segmental breathing exercise in which therapist will instruct the patients to inhale slowly through their nose, directing the air towards the target area. Physiotherapist will measure the expansion of that specific region through flexible curve as patient breathe in and out. Then therapist will give guide the patient to exhale slowly and completely through mouth, allowing the targeted area to relax. Diaphragmatic breathing exercise in which therapist will instruct the patient to start by taking a few slow, deep breaths through their nose. Guide the patient to inhale, physiotherapist will focus on expanding their abdomen, allowing it to rise and push their hand upward. Physiotherapist will guide the patients try to keep their chest relatively still during this phase. The patient will exhale slowly and completely through its mouth. As patient will exhale, therapist (WS) will measure patient’s abdomen falling and hand sinking back down through flexible curve. Ask the patient continue to breathe slowly and deeply in this manner, maintaining a relaxed and steady rhythm. Both techniques will be given to patients 2 sets once for 7days/week, (15 repetitions) for 15-20 minutes for 2 week preoperatively and postoperatively till discharged. Intervention 2: Control group: Incentive spirometry is a medical device and a respiratory therapy technique used to help patients improve their lung function, particularly after surgery or when they are at risk of developing respiratory complications. It encourages deep breathing and sustained lung inflation to prevent atelectasis (lung collapse) and other pulmonary problems. Ask the patient to inhale as slowly and as deeply as patient can through the mouthpiece or facemask to raise the indicator to the predetermined target or as instructed by healthcare provider. Keep patients lips tightly sealed around the mouthpiece or maintain a snug fit with the facemask. After reached the target, hold his/her breath for about 3-5 seconds. This allows the air to reach the deeper parts of lungs and helps to open up the small air sacs (alveoli).Exhale slowly and completely through your mouth, emptying the lungs. Take a moment to rest and breathe normally for a few breaths. Perform this process for the prescribed number of breaths or as instructed by healthcare provider. Typically, patients are advised to do 5-10 repetitions every hour while awake for 1-2 weeks before operation. Yes - There is a plan to make this available What will be shared: 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 When: After collecting from patients To whom: After data collection from patients Conditions: For study purpose only Where to obtain: From hospitals How to obtain: A written informed consent from university hospital and patients will be taken. Comments:
public Zulfiqar Haider
DHA Phase 1 Street 123 Lahore, Punjab
Lahore Pakistan 54000 +92 322 9996000 hzulfiqar35@yahoo.com National Hospital and Medical Centre Lahore Punjab scientific Zulfiqar Haider
DHA Phase 1 Street 123 Lahore, Punjab
Lahore Pakistan 54000 +92 322 9996000 hzulfiqar35@yahoo.com National Hospital and Medical Centre Lahore Punjab Pakistan Both male and female patients within the age of 40 to 70 will be eligible. Patients will be included based upon clinical symptoms, coronary angiography, 12 lead ECG, echocardiogram and routine basic blood investigations which will be complete blood count. Patients will be included based upon renal function tests, liver function tests, clotting profile, hepatitis screening. Patients will be included based upon blood grouping and cross match, chest x-ray and left ventricle ejection fraction ≥35% determined by echocardiogram. 40 years 70 years Both Emergent surgery due to unstable angina Hemodynamically unstable patients. Patients on preoperative inotropic support. Patients pericardial effusion and perioperative lung complication. Patient on steroids and bronchodilators. Patients with endocrine abnormalities such as hyper or hypothyroidism. Patients with neurological disability and/or musculoskeletal disorder. Concomitant valve disease. Patients having dysrhythmias or on permanent pacemaker and intra-aortic balloon pump. Anemic patient with hemoglobin less than 10 grams /dl. Pregnancy Obesity class II & III according to BMI >40kg/m2 Patients having Asthma, COPD and Interstitial Lung Disease I25.70 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris Other Rehabilitation Intervention group: Segmental breathing exercise in which therapist will instruct the patients to inhale slowly through their nose, directing the air towards the target area. Physiotherapist will measure the expansion of that specific region through flexible curve as patient breathe in and out. Then therapist will give guide the patient to exhale slowly and completely through mouth, allowing the targeted area to relax. Diaphragmatic breathing exercise in which therapist will instruct the patient to start by taking a few slow, deep breaths through their nose. Guide the patient to inhale, physiotherapist will focus on expanding their abdomen, allowing it to rise and push their hand upward. Physiotherapist will guide the patients try to keep their chest relatively still during this phase. The patient will exhale slowly and completely through its mouth. As patient will exhale, therapist (WS) will measure patient’s abdomen falling and hand sinking back down through flexible curve. Ask the patient continue to breathe slowly and deeply in this manner, maintaining a relaxed and steady rhythm. Both techniques will be given to patients 2 sets once for 7days/week, (15 repetitions) for 15-20 minutes for 2 week preoperatively and postoperatively till discharged. Control group: Incentive spirometry is a medical device and a respiratory therapy technique used to help patients improve their lung function, particularly after surgery or when they are at risk of developing respiratory complications. It encourages deep breathing and sustained lung inflation to prevent atelectasis (lung collapse) and other pulmonary problems. Ask the patient to inhale as slowly and as deeply as patient can through the mouthpiece or facemask to raise the indicator to the predetermined target or as instructed by healthcare provider. Keep patients lips tightly sealed around the mouthpiece or maintain a snug fit with the facemask. After reached the target, hold his/her breath for about 3-5 seconds. This allows the air to reach the deeper parts of lungs and helps to open up the small air sacs (alveoli).Exhale slowly and completely through your mouth, emptying the lungs. Take a moment to rest and breathe normally for a few breaths. Perform this process for the prescribed number of breaths or as instructed by healthcare provider. Typically, patients are advised to do 5-10 repetitions every hour while awake for 1-2 weeks before operation. Modified medical research council dyspnea scale. Timepoint: Baseline, preoperative after 2 weeks of treatment, postoperatively on day 1st, 2nd and before discharge from hospital. Method of measurement: Chest expansion by flexi-curve, modified medical research council dyspnea scale for dyspnea evaluation, pulmonary complication evaluation by using Chest Xray, Dyspnea (D-12) Questionnaire for shortness of breath. 1. Functional mobility 2. Chest expansion 3. Dyspnea 4. pulmonary complications 5. length of hospital stay. Timepoint: Baseline, preoperatively after 2 weeks of treatment, postoperatively on day 1st, 2nd and before hospital discharge. Method of measurement: Functional mobility scale, Chest expansion by flexi-curve, modified medical research council dyspnea scale for dyspnea evaluation, pulmonary complication evaluation by using Chest Xray, Dyspnea (D-12) Questionnaire for shortness of breath. National Hospital and medical Centre lahore Punjab Approved 2023-09-21 Lincoln University College Lincoln university college-Medical campus,2, Jalan Stadium SS 7/15, SS7, 47301 Petaling Jaya, Selangor, Malaysia Kuala Lumpur Selangor Malaysia