Protocol summary
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Study aim
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The effect of three and four phase early movement protocol on clinical outcomes in patients undergoing CABG
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Design
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This study is a single-blind randomized controlled trial with a parallel three-arm design. After obtaining the permission of the Ethics Committee and the study registration at the Iranian Registry of Clinical Trials, the eligible samples will be randomly assigned to a 1: 1: 1 ratio in three groups including two intervention and one control groups.
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Settings and conduct
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After registry of trial, the researcher will identify eligible patients in Shahid Madani Cardiac Surgery ward, Tabriz. They will be included in the study if they are eligible and consented. The participants with GCS = 14-15 will receive intervention in cardiology Intensive Care Unit after surgery. Intervention will be performed in the first two days following surgery after extubation for both groups. The four-phase and three-phase protocol will be performed for the intervention groups. For the control group, routine intervention will be done.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18 to 65, EF above 45%, no open sternectomy
Exclusion criteria: Unstable angina, respiratory cardiac arrest during or after surgery, MV duration above 24 hours
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Intervention groups
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Intervention group 1: Quadruple protocol of moving in bed, sitting in bed next to bed, walking in ward and stepping on a pedestal, Intervention group 2: three-phase protocol including the necessary measures for lung clearance, walking in the ward and taking steps on a pedestal, and control group will receive routine intervention.
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Main outcome variables
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mean arterial oxygen saturation، Frequency of cognitive status and pulmonary complications, mean pain score, after intervention in study groups
General information
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Reason for update
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Identify information with the submitted article.
The article is in the judging stage and one of the objections that must be resolved in order for the article to be accepted is the correction of the trial in the clinical trial center.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160110025937N5
Registration date:
2019-11-03, 1398/08/12
Registration timing:
registered_while_recruiting
Last update:
2021-07-12, 1400/04/21
Update count:
1
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Registration date
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2019-11-03, 1398/08/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-10-12, 1398/07/20
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Expected recruitment end date
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2019-11-10, 1398/08/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Random allocation is done using computer random numbers table
Ethics committees
1
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Ethics committee
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Approval date
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2019-09-11, 1398/06/20
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Ethics committee reference number
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Ir.tbzmed.rec.1398.613
Health conditions studied
1
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Description of health condition studied
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Chronic ischemic heart disease
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ICD-10 code
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I25.82
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ICD-10 code description
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chronic total occlusion of coronary artery
Primary outcomes
1
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Description
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Arterial oxygen saturation
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Timepoint
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Before the intervention, immediately after the intervention, 15 after intervention
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Method of measurement
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Using pulse oximetry and assessing arterial blood gases(ABG)
2
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Description
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pain
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Timepoint
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Before the intervention, immediately after the intervention, 15 after intervention
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Method of measurement
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Analog visual analogue tool: VAS (Visual Analogue Scale)
3
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Description
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Levels of cognitive status
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Timepoint
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Before the study, after reading and end intervention
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Method of measurement
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Short Psycho-Mental Testing Tool: MMSE (Mini-Mental State Examination)
4
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Description
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Frequency of pulmonary complications
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Timepoint
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Before the intervention, on the last day of intervention
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Method of measurement
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Using CXR and Physician Visit
5
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Description
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arterial blood gas
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Timepoint
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before intervention and after 15 minute after end intervention
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Method of measurement
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ABG
Secondary outcomes
1
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Description
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Duration of stay in hospital and ICU
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Timepoint
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On the day of the patient's discharge from ICU and Hospital
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Method of measurement
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The patient's stay in the hospital and ICU will be determined by calculating the days of admission
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).
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When the data will become available and for how long
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starting access immediately after publication
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To whom data/document is available
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Data will be available to researchers as well as to journals.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Refer to the email address (allahbakhshiana@tbzmed.ac.ir).
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What processes are involved for a request to access data/document
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The requests will be sent by email and data will be available within a week.
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Comments
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