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IRCT20150916024047N5 IRCT 2022-01-04 Mazandaran University of Medical Sciences The effect of breathing exercises on respiratory status after coronary artery bypass graft surgery The effect of breathing exercises on respiratory status after coronary artery bypass graft surgery 2021-11-22 anticipated 52 Complete https://irct.ir/trial/60128 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the limited randomization method of block randomization. The size of all blocks is equal and in this study we will have a trial of two intervention and control groups in 13 blocks of 4 (including 2 participants in the intervention group and 2 participants in the control group). Randomization tool also uses Sampling random sequence generation software that these random sequence generation software in addition to simple randomization are able to generate random sequences by blocking method. Using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the letter envelopes are glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: In this study, blinding was performed only on a person who evaluates patients' chest x-rays for atelectasis, who does not know which patients are in the intervention group and which patients are in the control group. N/A Condition 1: Coronary artery bypass graft surgery. Condition 2: Atelectasis. Intervention 1: Intervention group: The patient is instructed in diaphragmatic breathing and bud lip breathing, and motivational spirometry and effective coughing are performed in combination.The mentioned breathing exercises started one hour after removing the endotracheal tube under the supervision of the researcher or his colleague and will be performed until the 4th day after the surgery. Supervision of the nurse who is fully trained in how to perform exercises and research process, and the results will be recorded in the checklist of respiratory exercises demographic and medical information of patients including age, sex, marital status, education, history of smoking Height, weight, body mass index, and underlying disease (diabetes, hypertension, cardiomyopathy, etc.) will be collected and recorded using a questionnaire.Also, information about the surgical status including the location and number of transplanted vessels, the duration of surgery, the duration of use of the cardiopulmonary pump, the duration of use of artificial ventilation in the ICU and the duration of intubation during the patient care process will be recorded. Due to the fact that some studies have mentioned the maximum incidence of atelectasis in patients undergoing coronary artery bypass graft surgery on the third and fourth days after surgery, and in order not to impose additional burden on patients to undergo double radiography, in this study A chest radiograph will be taken on the day before surgery and at the end of the fourth day after surgery at 9 pm in patients in both groups.Diagnosis of atelectasis is based on the opinion of three radiologists and at least two of them confirm the existence of atelectasis and due to changes including Fisher interlobar displacement, increased density, crowded bronchovascular view, diaphragm in the same side, tracheal displacement, heart The medial side will be affected, the umbilicus will rise in lower lobe atelectasis, compensatory ventilation in other lobes, the hemithorax volume will decrease in the same direction, and the distance between the ribs will decrease. Arterial blood oxygen saturation (SpO2) and respiration rate per minute before induction of anesthesia and after removal of endotracheal tube, on the second, third, fourth day after surgery at 12 noon by pulse oximetry device ALBORZ b9 vital signs monitoring device Will be measured.Lung sound by 3M ™ Littmann® Classic III medical earphone one day before surgery, six hours after surgery every two hours, up to 24 hours after surgery every six hours, the second day every 12 hours and the third and fourth day once At 6 pm, the anesthesiologist will hear and diagnose abnormal sounds (cracking, whistling, extra noise, natural noise reduction, and hoarseness) with the doctor's advice. Intervention 2: Control group: Control group: Patients in the control group receive routine respiratory physiotherapy and at the end are compared with patients in the intervention group in terms of atelectasis and respiratory status. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Hedayat Jafari
Golestan Town, Baharestan Blvd., No. 24
Semnan Iran (Islamic Republic of) 3519798363 +98 21 8145 3535 hjafari@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Hedayat Jafari
Golestan Town, Baharestan Blvd., No. 24
Semnan Iran (Islamic Republic of) 3519798363 +98 21 8145 3636 hjafari@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old No ejection fraction less than 30% Lack of chronic respiratory diseases such as asthma and COPD No history of heart and lung surgery Not having any lung damage No history of rib fractures Not having any cognitive or neurological disorders No history of head or nose trauma and recurrent sinus infections No history of chemotherapy and use of immunosuppressive drugs in the three months before surgery No BMI more than 40 18 years no limit Both Severe hemodynamic disorders after surgery Arterial blood pH less than 7/30 Arterial carbon dioxide pressure more than 50 mm Hg Arterial oxygen saturation is less than 80% despite receiving supplemental oxygen Serum creatinine greater than 3.5 mg / dL Aortic collapse time more than 150 minutes Pulmonary bypass time more than 240 minutes Use of intra-aortic pump balloon during and after surgery Intubation for more than 24 hours Re-transfer of the patient to the operating room and the patient's need for a ventilation-treatment protocol outside the research process I25.810 J98.11 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris Atelectasis Treatment - Other Treatment - Other Intervention group: The patient is instructed in diaphragmatic breathing and bud lip breathing, and motivational spirometry and effective coughing are performed in combination.The mentioned breathing exercises started one hour after removing the endotracheal tube under the supervision of the researcher or his colleague and will be performed until the 4th day after the surgery. Supervision of the nurse who is fully trained in how to perform exercises and research process, and the results will be recorded in the checklist of respiratory exercises demographic and medical information of patients including age, sex, marital status, education, history of smoking Height, weight, body mass index, and underlying disease (diabetes, hypertension, cardiomyopathy, etc.) will be collected and recorded using a questionnaire.Also, information about the surgical status including the location and number of transplanted vessels, the duration of surgery, the duration of use of the cardiopulmonary pump, the duration of use of artificial ventilation in the ICU and the duration of intubation during the patient care process will be recorded. Due to the fact that some studies have mentioned the maximum incidence of atelectasis in patients undergoing coronary artery bypass graft surgery on the third and fourth days after surgery, and in order not to impose additional burden on patients to undergo double radiography, in this study A chest radiograph will be taken on the day before surgery and at the end of the fourth day after surgery at 9 pm in patients in both groups.Diagnosis of atelectasis is based on the opinion of three radiologists and at least two of them confirm the existence of atelectasis and due to changes including Fisher interlobar displacement, increased density, crowded bronchovascular view, diaphragm in the same side, tracheal displacement, heart The medial side will be affected, the umbilicus will rise in lower lobe atelectasis, compensatory ventilation in other lobes, the hemithorax volume will decrease in the same direction, and the distance between the ribs will decrease. Arterial blood oxygen saturation (SpO2) and respiration rate per minute before induction of anesthesia and after removal of endotracheal tube, on the second, third, fourth day after surgery at 12 noon by pulse oximetry device ALBORZ b9 vital signs monitoring device Will be measured.Lung sound by 3M ™ Littmann® Classic III medical earphone one day before surgery, six hours after surgery every two hours, up to 24 hours after surgery every six hours, the second day every 12 hours and the third and fourth day once At 6 pm, the anesthesiologist will hear and diagnose abnormal sounds (cracking, whistling, extra noise, natural noise reduction, and hoarseness) with the doctor's advice. Control group: Control group: Patients in the control group receive routine respiratory physiotherapy and at the end are compared with patients in the intervention group in terms of atelectasis and respiratory status. Respiratory status of patients after coronary artery bypass graft surgery. Timepoint: The second, third, fourth day after surgery. Method of measurement: The arterial blood oxygen saturation of the pulse oximetry device and the intensity of pain are assessed with a 10-point VAS visual criterion. Respiratory status. Timepoint: Periods of respiratory status assessment as a consequence can be stated at the beginning of the study (before the intervention) and the first, second and third days after the start of respiratory training. Method of measurement: Hearing the lungs of patients. Oxygen saturation rate. Timepoint: Arterial blood oxygen saturation on the second, third and fourth day after the start of breathing exercises. Method of measurement: Pulse oximetry. VAS standard score. Timepoint: VAS standard score after the end of the respiratory training course. Method of measurement: VAS criteria. Mazandaran University of Medical Sciences Approved 2021-11-03 Ethics committee of mazandaran University of Medical Sciences Golestan Town, Baharestan Blvd., No. 24 Mazandaran Mazandaran Iran (Islamic Republic of)