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IRCT20230123057185N1 IRCT 2023-03-17 Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan Comparison of incentive spirometry and peak expiratory flow meter to evaluate cardiorespiratory parameters after valvular surgery Comparison of incentive spirometry and peak expiratory flow meter to evaluate cardiorespiratory parameters after valvular surgery 2023-03-24 anticipated 64 Complete https://irct.ir/trial/69145 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization is simple. Total participants will be divided into two groups by lottery method. Each member of the population will be assigned by a number, after which members will be selected at random into groups. allocation concealment will also carried out, Blinding description: The allocation will be known to the patients, the doctor, and the data analyst. However, the interventionist's therapist will be kept unaware. The trial follows established protocols to keep the staff members who delivered the interventions apart from those who took part in other aspects of the trial. the interventional personnel will be maintained masked to outcomes measurements and trial data and to minimize the biasness. 1-2 Heart valvular surgery. Intervention 1: Intervention group 1: Incentive spirometry 1.The patient will be asked to lie flat on a bed or a chair. The patient will be asked to grasp a pillow to help corset or brace the incision to lessen the pain on chest. 2.The patients will also be instructed to place the mouthpiece in their mouth and seal their lips tightly around it before slowly and fully exhaling.3.The next step is to inhale via their mouth slowly and deeply. The ball will rise when the breath will be taken.4.Patient will be asked to try to get the ball as high as possible.5.The patient will be instructed to hold their breath for at least 10 seconds after receiving it.6.After that, he or she will slowly exhale through their mouth. Next, they will be asked to take a 30 to 60 second break.7 It will be repeated 10 times for 3 sets for 3 weeks. Intervention 2: Intervention group 2: Peak expiratory flow meter 1.Patient will be asked to stand or sit up straight. 2.It will be made sure the red marker is located at the meter’s base. 3.The patient will inhale deeply until their lungs are filled .4.The participant will put the mouthpiece in his/her mouth and then press their lips firmly against the mouthpiece of the peak flow meter. 5.Then he/she will expel all the air as quickly and forcefully as they can. 6.On the meter, the number next to the red marker will be noted. 7. Pressure will be continually turned up.8. Maximal expiratory pressure would be found at that point, and this is where training of patient will be started. The knob will be turned back to one, and then it will be fully turned to the left. 9.While training, patient will be asked to rest for a minimum of 15 to 20 seconds.10.One set is made up of 3 repetitions of this exercise. 11. 15 training breaths across 3 breath sets will be completed.12. Intervention will be done in 3 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of individual personal information
public Dr. Farah Zahid
Peera Ghaeeb road chock khumhara wala Multan
Multan Pakistan 66000 +92 306 1708076 farahzahid977@gmail.com Muhammad Institute of medical and Allied sciences Multan scientific Dr. Atiq-ul-Mannan
Tariq road Multan
Multan Pakistan 66000 +92 334 6036848 atiqulmannan23@gmail.com Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan Pakistan Patients of both sexes i-e male and female Patients with age ranges of (35-65yrs.) Patients who have recently undergone extubated heart valve surgery and who will be able to comply with the instructions and sign the consent form. Patients who underwent median sternotomy-based valvular surgery. Patients with stable hemodynamics 35 years 65 years Both Patients who needed to be intubated for more than 48 hours following surgery. Re-intubation throughout the healing process Patients who within the previous three months had a history of a respiratory infection Patients undergo CABG surgery. Patients with any neuromuscular disease, renal disease, smokers, alcohol, anemia, and pregnant females. Y83.1 Aortic regurgitation, Aortic stenosis, Mitral stenosis, Mitral regurgitation, Marfan's syndrome, Rheumatic fever, Endocarditis, Atresia, Heart valve disease, Valvular heart disease, Valvular surgery Rehabilitation Rehabilitation Intervention group 1: Incentive spirometry 1.The patient will be asked to lie flat on a bed or a chair. The patient will be asked to grasp a pillow to help corset or brace the incision to lessen the pain on chest. 2.The patients will also be instructed to place the mouthpiece in their mouth and seal their lips tightly around it before slowly and fully exhaling.3.The next step is to inhale via their mouth slowly and deeply. The ball will rise when the breath will be taken.4.Patient will be asked to try to get the ball as high as possible.5.The patient will be instructed to hold their breath for at least 10 seconds after receiving it.6.After that, he or she will slowly exhale through their mouth. Next, they will be asked to take a 30 to 60 second break.7 It will be repeated 10 times for 3 sets for 3 weeks. Intervention group 2: Peak expiratory flow meter 1.Patient will be asked to stand or sit up straight. 2.It will be made sure the red marker is located at the meter’s base. 3.The patient will inhale deeply until their lungs are filled .4.The participant will put the mouthpiece in his/her mouth and then press their lips firmly against the mouthpiece of the peak flow meter. 5.Then he/she will expel all the air as quickly and forcefully as they can. 6.On the meter, the number next to the red marker will be noted. 7. Pressure will be continually turned up.8. Maximal expiratory pressure would be found at that point, and this is where training of patient will be started. The knob will be turned back to one, and then it will be fully turned to the left. 9.While training, patient will be asked to rest for a minimum of 15 to 20 seconds.10.One set is made up of 3 repetitions of this exercise. 11. 15 training breaths across 3 breath sets will be completed.12. Intervention will be done in 3 weeks. Blood Pressure. Timepoint: Before interventions and after 3 weeks of interventions. Method of measurement: Cardiorespiratory parameters like blood pressure will be measured by Arterial line. Heart rate. Timepoint: Before interventions and after 3 weeks of interventions. Method of measurement: Cardiorespiratory parameters like heart rate will be measured by arterial line. Respiratory rate. Timepoint: Before interventions and after 3 weeks of interventions. Method of measurement: Cardiorespiratory parameters like respiratory rate will be measured by arterial line. ABG's ( Atrial blood gasses). Timepoint: Before interventions and after 3 weeks of interventions. Method of measurement: Cardiorespiratory parameters like ABG's (atrial blood gasses) will be measured by arterial line. Oxygen saturation. Timepoint: Before interventions and after 3 weeks of interventions. Method of measurement: Oxygen saturation will be measured by probe of pulse oximeter. Rating of perceived exertion. Timepoint: Before intervention and 3 weeks after intervention. Method of measurement: Rate of perceived exertion will be measured by Borg scale. SF8 quality of life (A questionnaire). Timepoint: Before intervention and 3 weeks after intervention. Method of measurement: patients will fill the SF8 quality of life questionnaire. Ch. Pervaiz Elahi Institute of Cardiology Hospital, Multan Approved 2022-12-16 Muhammad Institute of Medical and Allied Sciences Multan near sabzazar metro station Multan Multan Punjab Pakistan