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IRCT20160110025937N7 IRCT 2022-05-25 Tabriz University of Medical Sciences Comparison of the Effect of two Early Mobilization Protocols on Pain severity, Aterial Oxygen Saturation, Hemodynamics Parameters, Postoperative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery Comparison of the Effect of two Early Mobilization Protocols on Pain severity, Aterial Oxygen Saturation, Hemodynamics Parameters, Postoperative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery 2022-06-22 anticipated 90 Complete https://irct.ir/trial/63285 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible available samples will be randomly assigned to the control group, The First Intervention group, and the Second Intervention group by assigning a 1: 1: 1 ratio. Random Allocation Sequences will be generated by the non-research person using RAS (Random Allocation Software) Software and Random Blocking will be generated using 3 and 6 blocks for Allocation in three groups (two intervention groups and one control group). The allocation concealment will be done based on the generated sequence using opaque, closed and uniform envelopes numbered from number 1 to the end. The first person to enter the study will be given envelope number 1 and this process will continue until the end, Blinding description: The allocation hiding will be done based on the generated sequence using opaque, closed, and uniformly envelopes numbered from number 1 to the end. The first person to enter the study will be given envelope number 1 and this process will continue until the end. Therefore, the researcher and the subject will not have any information about the type of allocation received until the envelopes are opened. In this study, they will be a statistical analyzer and examine the outcome of the course. N/A chronic ischemic heart disease. Intervention 1: Intervention group: The intervention group includes progressive early mobilization based on the Morris protocol and modified by Azarafarin et al. Which will be performed in 6 stages: patients after surgery and admission to the intensive care unit according to the level of consciousness of patients based on coma criteria. Glasgow in case of full consciousness, ie GCS = 15 and according to inclusion and exclusion criteria for intervention, if eligible to perform the intervention, 6-8 hours after removal of the patient's endotracheal tube, which is installed for mechanical ventilation. And within 24 hours after surgery, early movement will be performed for the patientBefore performing the intervention, the patient will be evaluated using the mentioned instruments in terms of pain intensity, hemodynamic indicators, postoperative complications (pulmonary complications, deep vein thrombosis) and arterial blood oxygenation level using the mentioned instruments. And then this protocol will be implemented for the first intervention group. This protocol consists of 6 stages that are progressively monitored based on the patient's tolerance level and by the early movement team which includes a heart surgeon, anesthesiologist, nurse, physiotherapist, assistant nurse, twice a day at 10 am, 5 pm and 5 pm. The consecutive day will be performed from the first day after surgery (24 hours after surgery) and up to four days after that, ie the fifth day after surgery:1- The movements start from changing the position in the bed and then the head is raised 45 degrees. 2- The ROM movements are performed for the upper and lower limbs for 5 minutes. 3- The patient sits in the bed for 5 minutes with the help and support of the researcher. If the previous stage is tolerated, the patient will be placed on the edge of the bed with hanging legs for 5 minutes. 5. Based on the tolerance level, the patient is placed standing next to the bed for 5 minutes and then transferred to a chair next to the bed and placed in this position for 5 minutes. 6- In the last stage, the patient travels a distance for 6 minutes with the help of a nurse and with pulse oximetry and by controlling heart rate indicators and SPO2 and patient tolerance level and with confidence in connections and drainage pipes. Intervention 2: Intervention group: This protocol includes early mobilization and ocular strengthening exercises designed by Ayshegul yayla. This protocol is also performed by the early movement team, which includes a heart surgeon, anesthesiologist, nurse, physiotherapist, and nurse assistant, in the first 5 days after the operation, so that steps of this protocol are performed every day and go to The next few days the protocol will be more complete. The day operation protocol is 4 steps and the rest of the days are 5 steps. This protocol will be implemented twice at 11 am and 6 pm. Patients from surgery and admission to the surgical intensive care unit according to the level of consciousness of patients with Glasgow coma criterion in case of full consciousness, ie GCS = 15 and inclusion of inclusion and exclusion criteria for intervention.If eligible for the intervention, 6-8 hours after removal of the patient's endotracheal tube, which was installed for mechanical ventilation, the pre-test is performed as in the previous intervention and the intervention is performed. Thus: On the day of operation (day zero): 8 hours after the exit of the endotracheal tube is raised 30 to 45 degrees and encouraging spirometry, deep breathing exercises and cough eight times a day (twice a day, 4 sets each time) it is possible. Then, inactive limb exercises are performed twice a day for 5 sets each time for 10 minutes based on patient tolerance. Finally, patients sit by the bed twice a day for 15 minutes each time. The first day after surgery or 24 hours after surgery: The head is still 30 to 45 degrees high and encouraging spirometry and effective breathing exercises and coughing are performed twice a day and 4 sets each time.In the third stage, inactive exercises twice a day and 5 sets each time for 10 minutes based on the patient's tolerance level. 4- The patient sits in a bedside chair twice a day for 20 minutes each time. He walks 150 steps. The second day after the operation: up to stage 4, like the first day after the operation, then in the last stage, the patient walks 250 steps in the ward twice a day. Day 3 after the operation: the first, second and third stages, like the previous days, run In the fourth stage, the patient sits on a chair twice a day for 30 minutes instead of 20 minutes and then walks four hundred steps twice a day. The fourth day after the operation: All three stages are performed as in the previous days and in the fourth stage The patient sits on a chair for 45 minutes twice a day and finally walks 400 steps in the ward twice a day. Intervention 3: Control group: For the control group, routine measures will be performed to perform early movement. Routine measures for early movement in the intensive care unit of cardiac surgery of Shahid Madani Hospital in Tabriz during the inquiry of nurses working in these wards are as follows: After complete orientation of patients and removal of the patient's endotracheal tube 24 hours after surgery under the supervision of a nurse and Accompanied by the patient's nurse, he first hangs his legs from the bed for 5 minutes and then, if the patient tolerates, gets out of bed and travels a tolerable distance, and this is done twice a day until the discharge from the ICU. Yes - There is a plan to make this available What will be shared: The information requested by the researchers for statistical analysis of the submitted proposal (meta-analysis) will be provided to them When: Starting access immediately after publication To whom: Data will be available to researchers as well as to journals Conditions: The data will be available to researchers upon request and submission of a meta-analysis proposal using IPD data after individuals have been identified. It will also be made available to journals exclusively for exceptional data checking. Where to obtain: Refer to allahbakhshiana@tbzmed.ac.ir How to obtain: Requests will be emailed and data will be available within a week. Comments:
public Dr Atefe Allahbakhshian
Tabriz, South Shariati St., School of Nursing and Midwifery, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 allahbakhshiana@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Atefe Allahbakhshian
Tabriz, South Shariati St., School of Nursing and Midwifery, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 allahbakhshiana@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Stable Hemodynamics Absence of Motor, Auditory and Visual Problems Lack of Respiratory Distress 18 years no limit Both Open Sternum Uncontrollable Dysrhythmia Cardiac Arrest during Surgery and after Admission to the ICU Mechanical Ventilation Duration more than 24 hours I25.82 Chronic total occlusion of coronary artery Rehabilitation Rehabilitation Rehabilitation Intervention group: The intervention group includes progressive early mobilization based on the Morris protocol and modified by Azarafarin et al. Which will be performed in 6 stages: patients after surgery and admission to the intensive care unit according to the level of consciousness of patients based on coma criteria. Glasgow in case of full consciousness, ie GCS = 15 and according to inclusion and exclusion criteria for intervention, if eligible to perform the intervention, 6-8 hours after removal of the patient's endotracheal tube, which is installed for mechanical ventilation. And within 24 hours after surgery, early movement will be performed for the patientBefore performing the intervention, the patient will be evaluated using the mentioned instruments in terms of pain intensity, hemodynamic indicators, postoperative complications (pulmonary complications, deep vein thrombosis) and arterial blood oxygenation level using the mentioned instruments. And then this protocol will be implemented for the first intervention group. This protocol consists of 6 stages that are progressively monitored based on the patient's tolerance level and by the early movement team which includes a heart surgeon, anesthesiologist, nurse, physiotherapist, assistant nurse, twice a day at 10 am, 5 pm and 5 pm. The consecutive day will be performed from the first day after surgery (24 hours after surgery) and up to four days after that, ie the fifth day after surgery:1- The movements start from changing the position in the bed and then the head is raised 45 degrees. 2- The ROM movements are performed for the upper and lower limbs for 5 minutes. 3- The patient sits in the bed for 5 minutes with the help and support of the researcher. If the previous stage is tolerated, the patient will be placed on the edge of the bed with hanging legs for 5 minutes. 5. Based on the tolerance level, the patient is placed standing next to the bed for 5 minutes and then transferred to a chair next to the bed and placed in this position for 5 minutes. 6- In the last stage, the patient travels a distance for 6 minutes with the help of a nurse and with pulse oximetry and by controlling heart rate indicators and SPO2 and patient tolerance level and with confidence in connections and drainage pipes Intervention group: This protocol includes early mobilization and ocular strengthening exercises designed by Ayshegul yayla. This protocol is also performed by the early movement team, which includes a heart surgeon, anesthesiologist, nurse, physiotherapist, and nurse assistant, in the first 5 days after the operation, so that steps of this protocol are performed every day and go to The next few days the protocol will be more complete. The day operation protocol is 4 steps and the rest of the days are 5 steps. This protocol will be implemented twice at 11 am and 6 pm. Patients from surgery and admission to the surgical intensive care unit according to the level of consciousness of patients with Glasgow coma criterion in case of full consciousness, ie GCS = 15 and inclusion of inclusion and exclusion criteria for intervention.If eligible for the intervention, 6-8 hours after removal of the patient's endotracheal tube, which was installed for mechanical ventilation, the pre-test is performed as in the previous intervention and the intervention is performed. Thus: On the day of operation (day zero): 8 hours after the exit of the endotracheal tube is raised 30 to 45 degrees and encouraging spirometry, deep breathing exercises and cough eight times a day (twice a day, 4 sets each time) it is possible. Then, inactive limb exercises are performed twice a day for 5 sets each time for 10 minutes based on patient tolerance. Finally, patients sit by the bed twice a day for 15 minutes each time. The first day after surgery or 24 hours after surgery: The head is still 30 to 45 degrees high and encouraging spirometry and effective breathing exercises and coughing are performed twice a day and 4 sets each time.In the third stage, inactive exercises twice a day and 5 sets each time for 10 minutes based on the patient's tolerance level. 4- The patient sits in a bedside chair twice a day for 20 minutes each time. He walks 150 steps. The second day after the operation: up to stage 4, like the first day after the operation, then in the last stage, the patient walks 250 steps in the ward twice a day. Day 3 after the operation: the first, second and third stages, like the previous days, run In the fourth stage, the patient sits on a chair twice a day for 30 minutes instead of 20 minutes and then walks four hundred steps twice a day. The fourth day after the operation: All three stages are performed as in the previous days and in the fourth stage The patient sits on a chair for 45 minutes twice a day and finally walks 400 steps in the ward twice a day. Control group: For the control group, routine measures will be performed to perform early movement. Routine measures for early movement in the intensive care unit of cardiac surgery of Shahid Madani Hospital in Tabriz during the inquiry of nurses working in these wards are as follows: After complete orientation of patients and removal of the patient's endotracheal tube 24 hours after surgery under the supervision of a nurse and Accompanied by the patient's nurse, he first hangs his legs from the bed for 5 minutes and then, if the patient tolerates, gets out of bed and travels a tolerable distance, and this is done twice a day until the discharge from the ICU. Pain severity. Timepoint: Before Intervention, Immediately after Intervention, 15 minutes after Intervention. Method of measurement: Visual Analogue Scale. Aterial Oxygen Saturation. Timepoint: Before intervention, َAfter intervention. Method of measurement: Using Pulse Oximetry. Hemodynamics Parameters. Timepoint: Before Intervention, Immediately after Intervention, 15 minutes after Intervention. Method of measurement: Monitoring device. Postoperative Complications. Timepoint: Before intervention, َAfter intervention. Method of measurement: Using Chest X Ray and Doctor Visits. Length of Hospital Stay. Timepoint: On the day of discharge from the hospital. Method of measurement: By calculating the number of days hospitalized. Tabriz University of Medical Sciences Approved 2022-05-11 Ethics Committee of Tabriz University of Medical Sciences Tabriz, Golgasht St., Tabriz University of Medical Sciences, Central Building No. 2, 3rd Floor Tabriz East Azarbaijan Iran (Islamic Republic of)