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IRCT20240104060613N1 IRCT 2024-02-02 Zahedan University of Medical Sciences Investigating the Effect of High-Flow Oxygen Administration on the Weaning Outcomes of Patients from Mechanical Ventilation After Coronary Artery Bypass Graft Surgery Investigating the Effect of High-Flow Oxygen Administration on the Weaning Outcomes of Patients from Mechanical Ventilation After Coronary Artery Bypass Graft Surgery 2024-01-16 anticipated 80 Complete https://irct.ir/trial/74965 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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. N/A Coronary Artery Disease. Intervention 1: 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. Intervention 2: 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%. Yes - There is a plan to make this available What will be shared: After completing the study, data extraction and analysis will be published as an article. When: After completing the study, data extraction and analysis will be published as an article. To whom: After completing the study, data extraction and analysis will be published as an article. Conditions: After completing the study, data extraction and analysis will be published as an article. Where to obtain: After completing the study, data extraction and analysis will be published as an article. How to obtain: After completing the study, data extraction and analysis will be published as an article. Comments:
public Abdolrab Dorazehi
No.13, Infront of Azadi 50, South Azadi Blvd, Iranshahr Town
Iranshahr Iran (Islamic Republic of) 9914943749 +98 54 3722 6364 abdoldora1990@gmail.com Zahedan University of Medical Sciences scientific Abdolrab Dorazehi
No.13, Infront of Azadi 50, South Azadi Blvd, Iranshahr Town
Iranshahr Iran (Islamic Republic of) 9914943749 +98 54 3722 6364 abdoldora1990@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) 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). 18 years no limit Both Severe pneumonia and acute respiratory failure during the study Persistent ventricular tachycardia requiring therapeutic intervention Unplanned extubation by the patient Need for tracheostomy placement I25.1 Atherosclerotic heart disease of native coronary artery Prevention Prevention 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. 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%. Reintubation rate. Timepoint: Forty-eight hours after weaning patients from the ventilator. Method of measurement: Extubation intolerance leading to respiratory failure and reintubation within 48 hours of weaning. Arterial blood carbon dioxide pressure (PaCO2). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: It will be measured through arterial blood gas analysis. Arterial oxygen pressure (PaO2). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: It will be measured through arterial blood gas analysis. Arterial blood bicarbonate (HCO3). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: It will be measured through arterial blood gas analysis. Arterial oxygen saturation percentage (SPO2). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: It is measured through pulse oximeter and arterial blood gas analysis. PaO2/FiO2 ratio. Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: It is calculated by dividing the arterial blood oxygen pressure measured by arterial blood gas analysis by the percentage fractional inspired oxygen (PaO2/FiO2). Heart Rate (HR). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: Heart rate is measured via bedside monitoring. Mean arterial pressure (MAP). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: Mean arterial pressure (MAP) is measured via patient bedside monitoring. Systolic blood pressure (SBP). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: Systolic blood pressure is measured via patient bedside monitoring. Diastolic blood pressure (DBP). Timepoint: Measurements will be recorded immediately before extubation, and then 6 and 12 hours post-extubation. Method of measurement: Diastolic blood pressure is measured via patient bedside monitoring. ICU long stay (ILS). Timepoint: 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. Method of measurement: 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. Hospital long stay (HLS). Timepoint: From the day of coronary artery bypass surgery until the day of discharge from the hospital. Method of measurement: 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. Mortality. Timepoint: 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. Method of measurement: The mortality rate of patients will be recorded until they are discharged from the hospital. Zahedan University of Medical Sciences Approved 2023-12-24 Ethics committee of Zahedan University of Medical Sciences Sistan and Baluchestan Province, Zahedan, Emam Hosain Blvd Integrating the campus of the University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)