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IRCT20160110025937N5 IRCT 2019-11-03 Tabriz University of Medical Sciences Comparison of The effect of early mobilization protocol at three and four phase on clinical outcome in patients undergoing coronary artery bypass graft:a single blinded randomized clinical trial Comparison of The effect of early mobilization protocol at three and four phase on clinical outcome in patients undergoing coronary artery bypass graft:a single blinded randomized clinical trial 2019-10-12 anticipated 120 Complete https://irct.ir/trial/40561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Random allocation is done using computer random numbers table, Randomization description: The present study is a single-blind randomized clinical trial with a three-arm parallel design. After obtaining the permission of the Ethics Committee and the registration of the study at the Iranian Center for Clinical Trials, available randomly selected samples will be randomly assigned with a 1: 1: 1 ratio in the control group and the first intervention group and the intervention group. Random assignment sequence by non-person involved in research using RAS software (Random Allocation Software) and random blocking will be generated using three and six blocks for assignment in three groups (two intervention groups and a control group). Became Hiding allocation based on the generated sequence will be done using matte envelopes, both closed and shaped, numbered from the number 1 to the end. The first person to enter the study will be enveloped No. 1, and this process will continue until the end . Therefore, the researcher and the person under study will not be informed of the type of allocation (Received Allocation Concealment) until the envelopes are unlocked. In this study, the statistical analyzes and the consequences of the outcome will only be blind. Information about the research objectives and its importance to the company They are given confidential information and their responses. Prior to the beginning of the study, written consent of each participant is taken, Blinding description: Hiding allocation based on Sequence generated using opaque and envelope envelopes The shape numbered from the number 1 to the end will be done. The first person to be included in the study is envelope # 1 data And this process will continue until the end. So The researcher and the person under study were allotted Concealment) will not be known until the envelopes are opened Had In this analytical and statistical analytic study The consequences will only be blinding. 2 Chronic ischemic heart disease. Intervention 1: Intervention group 1: Implementation of four phase early movement protocol for Intervention group 1: Intervention will be performed in two days the first day 24 hours after surgery and after endotracheal tube removal and the second day 48 hours after surgery. The four-phase protocol of moving in bed, sitting in a chair next to the bed, walking in sections and stepping on a pedestal for the first group were compared and the results were compared using the scales listed in the tool section and compared with the other groups. Intervention 2: Intervention group 2: Implementation of three-phase early motion protocol for intervention group 2: Intervention in two days, the first day 24 hours after surgery and after endotracheal tube removal and the second day 48 hours after surgery. The three-phase protocol protocol will focus on the second intervention group, with more focus on pulmonary exercises (including the necessary steps to clear the lungs) (in the methodology section), walking the ward and taking steps on a pedestal. And the groups will be compared. Intervention 3: Control group: Perform routine procedures for the control group: The control group will receive routine actions that involve lowering the bed and walking in the ward 24 hours after surgery. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). 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 proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking. Where to obtain: Refer to the email address (allahbakhshiana@tbzmed.ac.ir). How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Dr Atefeh Allahbakhshian
Tabriz School of Nursing and Midwifery, Southern Shariati St., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 6770 3479 41 +98 allahbakhshiana@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr Atefeh Allahbakhshian
Tabriz School of Nursing and Midwifery, Southern Shariati St., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 6770 3479 41 +98 allahbakhshiana@tbzmedn.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Selecting units from both ages 18 to 65 years 2. Having a BMI between 20 and 30 mg / m2 3. Stable hemodynamic status without taking inotropic drugs 4. Lack of arrhythmias and angina 5. No Significance of Respiratory Distress and RR under 20 without Symptoms of Systemic Infection. 6.Lack of Motor and Neurological Problems 7.Static pressure above 90 mmHg 8. Time of pump pulmonary than 90 minutes 9. As an expert in cardiac surgery 10. Having no previous history of pulmonary disease 11. A psychological and mental illness that will be examined by examining a patient's case and completing a mental-mental mental test questionnaire (MMSE) before entering the study. If the MMSE score of the patient in the heart surgery department and before entering the intensive care unit in the range of 30 -25 were enrolled in the study and will be excluded from the study if they have dementia and pathologic features. 18 years 65 years Both Exclusion criteria: 1. Cardiovascular and respiratory tract during and after admission in the ICU 2. Time for mechanical ventilation over 24 hours 3. Heart rate above 120 or uncontrolled arrhythmias 4. Unstable angina 5. Open sternum 6. Oxygen substitution under 90 7. Taccharide and bradycardia 8. EF below 40 9. No ability to communicate after entering the intensive care unit 10. The chest tube thickness is more than 100 cc at four hours 11. The time of the heart-pulmonary pump is 90 minutes. I25.82 chronic total occlusion of coronary artery Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Implementation of four phase early movement protocol for Intervention group 1: Intervention will be performed in two days the first day 24 hours after surgery and after endotracheal tube removal and the second day 48 hours after surgery. The four-phase protocol of moving in bed, sitting in a chair next to the bed, walking in sections and stepping on a pedestal for the first group were compared and the results were compared using the scales listed in the tool section and compared with the other groups. Intervention group 2: Implementation of three-phase early motion protocol for intervention group 2: Intervention in two days, the first day 24 hours after surgery and after endotracheal tube removal and the second day 48 hours after surgery. The three-phase protocol protocol will focus on the second intervention group, with more focus on pulmonary exercises (including the necessary steps to clear the lungs) (in the methodology section), walking the ward and taking steps on a pedestal. And the groups will be compared Control group: Perform routine procedures for the control group: The control group will receive routine actions that involve lowering the bed and walking in the ward 24 hours after surgery. Arterial oxygen saturation. Timepoint: Before the intervention, immediately after the intervention, 15 after intervention. Method of measurement: Using pulse oximetry and assessing arterial blood gases(ABG). Pain. Timepoint: Before the intervention, immediately after the intervention, 15 after intervention. Method of measurement: Analog visual analogue tool: VAS (Visual Analogue Scale). Levels of cognitive status. Timepoint: Before the study, after reading and end intervention. Method of measurement: Short Psycho-Mental Testing Tool: MMSE (Mini-Mental State Examination). Frequency of pulmonary complications. Timepoint: Before the intervention, on the last day of intervention. Method of measurement: Using CXR and Physician Visit. Arterial blood gas. Timepoint: before intervention and after 15 minute after end intervention. Method of measurement: ABG. Duration of stay in hospital and ICU. Timepoint: On the day of the patient's discharge from ICU and Hospital. Method of measurement: The patient's stay in the hospital and ICU will be determined by calculating the days of admission. Tabriz University of Medical Sciences Approved 2019-09-11 Ethics committe of Tabriz university of medical sciences Tabriz University of Medical Sciences, Golgasht ave. Tabriz East Azarbaijan Iran (Islamic Republic of)