Protocol summary
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Study aim
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Determining the Effect of High-Flow Oxygen on Weaning Outcomes from Ventilator in Patients After Coronary Artery Bypass Grafting.
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Design
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Control and intervention groups is conducted on 80 patients undergoing coronary artery bypass graft surgery. Patients were included in the study using a convenience sampling method and then divided into two groups using a simple randomization method.
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Settings and conduct
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Patients undergoing CABG admitted to the cardiac surgery ICU were included based on inclusion criteria and randomized to control or intervention groups. Ventilator weaning readiness was then assessed using the Burns Wean Assessment Program, and patients scoring above 17 were weaned. The intervention group will receive high-flow oxygen for 12 hours, while the control group receives oxygen via nasal cannula. Outcomes will be measured and compared between groups immediately pre-extubation, and at 6 and 12 hours post-extubation.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
1.Age ≥18 years old,
2.Mechanical ventilation for a minimum of 12 hours and a maximum of 48 hours
3.No significant bleeding occurred post-surgery (defined as bleeding from the chest tube exceeding 200 ml every hour in the first three hours post-operation).
Exclusion Criteria:
1.Severe pneumonia and acute respiratory failure during the study,
2.Persistent ventricular tachycardia requiring therapeutic intervention,
3.Unplanned extubation by the patient
4.Need for tracheostomy placement
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Intervention groups
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The intervention group will receive high-flow oxygen, while the control group will receive oxygen via nasal cannula.
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Main outcome variables
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reintubation, arterial blood gas analysis (ABG), ratio of arterial oxygen pressure to inspiratory oxygen fraction, heart rate, mean arterial pressure, systolic blood pressure, diastolic blood pressure, ICU long sta, hospital long stay, mortality
General information
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Reason for update
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A more accurate translation of the title has been provided.
The inclusion and exclusion criteria were changed and revised before the study commenced.
The mortality variable was removed from the study's exclusion criteria due to being measured as a secondary outcome.
The order of primary and secondary outcomes was revised based on the timing of their measurements.
A more accurate translation of the method of randomization has been provided.
The method of measurement and description of the variables were edited.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240104060613N1
Registration date:
2024-02-02, 1402/11/13
Registration timing:
registered_while_recruiting
Last update:
2025-03-31, 1404/01/11
Update count:
1
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Registration date
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2024-02-02, 1402/11/13
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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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2024-01-16, 1402/10/26
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Expected recruitment end date
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2024-12-21, 1403/10/01
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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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Investigating the Effect of High-Flow Oxygen Administration on the Weaning Outcomes of Patients from Mechanical Ventilation After Coronary Artery Bypass Graft Surgery
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Public title
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Investigating the Effect of High-Flow Oxygen Administration on the Weaning Outcomes of Patients from Mechanical Ventilation After Coronary Artery Bypass Graft Surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ≥18 years old
Mechanical ventilation for a minimum of 12 hours and a maximum of 48 hours
No significant bleeding occurred post-surgery (defined as bleeding from the chest tube exceeding 200 ml every hour in the first three hours post-operation).
Exclusion criteria:
Severe pneumonia and acute respiratory failure during the study
Persistent ventricular tachycardia requiring therapeutic intervention
Unplanned extubation by the patient
Need for tracheostomy placement
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients undergoing mechanical ventilation who met the inclusion criteria were selected using a convenience sampling method and then assigned to two intervention and control groups using a simple randomization method using blue and red colored cards. A total of 80 cards (40 blue cards and 40 red cards) will be prepared in an envelope. The blue cards will be designated for the intervention group, while the red cards will be designated for the control group. Upon the admission of each patient to the intensive care unit, one card will be drawn from the envelope. If a blue card is drawn, the patient will be assigned to the intervention group; if a red card is drawn, the patient will be assigned to the control group. This process will continue until the eightieth card is drawn from the envelope
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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Ethics committees
1
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Ethics committee
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Approval date
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2023-12-24, 1402/10/03
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Ethics committee reference number
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IR.ZAUMS.REC.1402.388
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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Reintubation rate
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Timepoint
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Forty-eight hours after weaning patients from the ventilator.
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Method of measurement
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Extubation intolerance leading to respiratory failure and reintubation within 48 hours of weaning.
2
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Description
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Arterial blood carbon dioxide pressure (PaCO2)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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It will be measured through arterial blood gas analysis.
3
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Description
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Arterial oxygen pressure (PaO2)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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It will be measured through arterial blood gas analysis.
4
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Description
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Arterial blood bicarbonate (HCO3)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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It will be measured through arterial blood gas analysis.
5
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Description
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Arterial oxygen saturation percentage (SPO2)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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It is measured through pulse oximeter and arterial blood gas analysis.
6
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Description
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PaO2/FiO2 ratio
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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It is calculated by dividing the arterial blood oxygen pressure measured by arterial blood gas analysis by the percentage fractional inspired oxygen (PaO2/FiO2).
7
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Description
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Heart Rate (HR)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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Heart rate is measured via bedside monitoring.
8
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Description
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Mean arterial pressure (MAP)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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Mean arterial pressure (MAP) is measured via patient bedside monitoring.
9
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Description
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Systolic blood pressure (SBP)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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Systolic blood pressure is measured via patient bedside monitoring.
10
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Description
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Diastolic blood pressure (DBP)
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Timepoint
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Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation.
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Method of measurement
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Diastolic blood pressure is measured via patient bedside monitoring.
Secondary outcomes
1
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Description
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ICU long stay (ILS)
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Timepoint
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The duration of stay in the intensive care unit (ICU) for open-heart surgery patients is calculated from the day of admission to the day of discharge.
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Method of measurement
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The number of days admitted to the intensive care unit of patients after coronary artery bypass graft surgery is calculated and recorded from the day of admission to the open heart intensive care unit until discharge from this unit.
2
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Description
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Hospital long stay (HLS)
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Timepoint
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From the day of coronary artery bypass surgery until the day of discharge from the hospital
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Method of measurement
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The number of days after coronary artery bypass graft surgery will be calculated and recorded from the day of admission to the intensive care unit until the day of discharge from the hospital.
3
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Description
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Mortality
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Timepoint
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The mortality rate of patients from the time of admission to discharge from the hospital will be recorded in two groups of intervention and control.
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Method of measurement
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The mortality rate of patients will be recorded until they are discharged from the hospital.
Intervention groups
1
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Description
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Intervention Group: In the intervention group, after extubation, high-flow oxygen therapy will be administered using a high-flow oxygen delivery device through a nasal cannula for up to 12 hours. Select an appropriately sized nasal cannula to prevent nasal discomfort. Patients' nostrils are lubricated with petroleum jelly to reduce the risk of epistaxis and dry mucous membranes. The initial oxygen flow rate will be set at 10 liters per minute, and if patients are comfortable, the flow rate will be increased by 5 liters per minute. The temperature of the delivered oxygen will be set at 37 degrees Celsius, and if the patient experiences discomfort, the oxygen temperature will be reduced by one degree down to a minimum of 35 degrees Celsius.The prescribed oxygen flow will be adjusted based on the patients' blood oxygen saturation levels, decreasing or increasing by 5 liters per minute to maintain arterial oxygen saturation levels measured by a pulse oximeter above 90 percent. After 12 hours, high-flow oxygen therapy will be stopped, and if patients still require oxygen administration, oxygen therapy will continue with a simple face mask at a flow rate of 5 to 10 liters per minute based on the patients' needs.
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Category
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Prevention
2
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Description
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Control Group: In the control group, after extubation, patients will receive oxygen via nasal cannula at 6-10 L/min, titrated to maintain oxygen saturation above 90%.
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Category
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Prevention
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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Zahedan 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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After completing the study, data extraction and analysis will be published as an article.
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When the data will become available and for how long
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After completing the study, data extraction and analysis will be published as an article.
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To whom data/document is available
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After completing the study, data extraction and analysis will be published as an article.
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Under which criteria data/document could be used
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After completing the study, data extraction and analysis will be published as an article.
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From where data/document is obtainable
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After completing the study, data extraction and analysis will be published as an article.
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What processes are involved for a request to access data/document
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After completing the study, data extraction and analysis will be published as an article.
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Comments
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