Determining the impact of high-flow oxygen administration on the outcomes of weaning patients from ventilators after coronary artery bypass graft surgery.
Design
A clinical trial with a control group, with parallel groups on 80 patients who are included in the study by a simple randomization method
Settings and conduct
After entering the cardiac surgery intensive care unit, the patients will be randomized and the intervention group will receive high-flow oxygenation for 12 hours, and the control group will receive oxygenation with a simple nasal cannula or with a face mask. Outcome variables will be measured and recorded in two groups on three occasions, immediately before extubation, 6 hours later and 12 hours later.
Participants/Inclusion and exclusion criteria
Entry requirements:
1- Age above 18 years
2- Not having mechanical ventilation for more than seven days
3- Not having coagulation disorders (bleeding from the chest tube more than 200 ml in the first three hours after the operation)
4- Lack of blood transfusion of more than three units
5- Not having a tracheostomy
6- Absence of unplanned separation
7- Obtaining a score equal to and greater than 17 from the Beren scale
Non-entry conditions:
1-Severe pneumonia and acute respiratory failure while studying
2- The patient died while conducting the study
3- Unplanned extubation by the patient himself
Intervention groups
The intervention group will receive high-flow oxygenation and the control group will receive oxygenation with a simple face mask or a simple nasal cannula
Main outcome variables
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, duration of hospitalization in the care department Specifically, length of hospital stay, mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240104060613N1
Registration date:2024-02-02, 1402/11/13
Registration timing:registered_while_recruiting
Last update:2024-02-02, 1402/11/13
Update count:1
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
Abdolrab Dorazehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3722 6364
Email address
abdoldora1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-16, 1402/10/26
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of High Flow Oxygen on Weaning Outcomes from Ventilator in Patients with Coronary Artery Bypass Graft Surgery
Public title
The Effect of High Flow Oxygen on Weaning Outcomes from Ventilator in Patients with Coronary Artery Bypass Graft Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
No mechanical ventilation for more than seven days
Not having coagulation disorders (bleeding from the chest tube more than 200 ml in the first three hours after the operation)
No large transfusion of more than three units of blood
Not having a tracheostomy
Absence of unplanned isolation
Obtaining a score equal to and greater than 17 from the Buren scale
Exclusion criteria:
Severe pneumonia and acute respiratory failure while studying
Death of the patient during the study
Unplanned extubation by the patient (herself/himself)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, after visiting the researcher, he will visit the research environment (open heart intensive care unit) where patients are transferred after coronary artery bypass surgery. While receiving mechanical ventilation, patients who meet the study entry criteria will be selected by available sampling method and then by simple randomization by lottery with blue and red color cards. 80 cards (40 blue cards and 40 red cards) are prepared in one envelope.Blue cards are considered for the intervention group and red cards for the control group. When each patient enters the intensive care unit, a card is removed from the envelope. If the desired card is blue, the patient will be in the intervention group, and if a red card is removed, the patient will be in the control group. This process will continue until the 80th card is removed from the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Sistan and Baluchestan Province, Zahedan, Emam Hosain Blvd Integrating the campus of the University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.ZAUMS.REC.1402.388
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Reintubation
Timepoint
48 hours after weaning from the ventilator
Method of measurement
Tolerating the removal of the tracheal tube by the patient and not causing respiratory failure up to 48 hours after being separated from the ventilator.
Secondary outcomes
1
Description
arterial blood carbon dioxide pressure
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
It will be extracted and recorded from arterial blood gas analysis
2
Description
Arterial oxygen pressure
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
It will be extracted and recorded from arterial blood gas analysis
3
Description
Arterial blood bicarbonate
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
It will be extracted and recorded from arterial blood gas analysis
4
Description
Oxygen saturation percentage of arterial blood
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
Arterial blood oxygen saturation percentage measured after coronary artery bypass graft surgery by pulse oximeter or arterial blood gases
5
Description
Ratio of arterial oxygen pressure to inspiratory oxygen fraction
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
After coronary artery bypass surgery, it is calculated through arterial blood gases and the percentage of inspiratory oxygen prescribed for the patient
6
Description
Heart rate
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
The number of heart beats after coronary artery bypass surgery is measured through patient monitoring
7
Description
Mean arterial pressure
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
After coronary artery bypass surgery, it is measured through patient monitoring
8
Description
Systolic blood pressure
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
After coronary artery bypass surgery, it is measured through patient monitoring
9
Description
Diastolic blood pressure
Timepoint
It will be measured and recorded 6 and 12 hours after the endotracheal tube is removed
Method of measurement
After coronary artery bypass surgery, it is measured through patient monitoring
10
Description
Duration of hospitalization in the intensive care unit
Timepoint
From the day of entering the open heart intensive care unit to the day of leaving the unit
Method of measurement
After coronary artery bypass surgery and entering the open heart intensive care unit, it is calculated until discharge from the intensive care unit
11
Description
Duration of hospitalization
Timepoint
After coronary artery bypass graft surgery until the day of discharge from the hospital
Method of measurement
After coronary artery bypass surgery, it will be calculated until the day the patient is in the hospital
12
Description
death
Timepoint
Mortality rate of patients until hospitalization
Method of measurement
Mortality rate of patients until hospitalization
Intervention groups
1
Description
Intervention group: In the intervention group, after removing the tracheal tube, high-flow oxygen therapy with a high-flow oxygen delivery device will be prescribed through the nasal cannula for up to 12 hours. The appropriate size of the nasal cannula will be selected for the patient in order to avoid the discomfort of the septum and nasal lobes. The entrance of the nostrils of the patients in the intervention group is lubricated with Vaseline to reduce the risk of epistaxis and dry mucus. The intensity of the oxygen flow will be set at 10 liters per minute first, and if the patients are not uncomfortable, the intensity of the oxygen flow will be increased by 5 liters per minute. The prescribed oxygen temperature is set at 37 degrees Celsius, and if the patient is uncomfortable, the oxygen temperature is reduced by one degree to a floor of 35 degrees Celsius. Prescribed oxygen flow will be increased and decreased by five liters per minute based on the oxygen saturation level of the patients' blood to maintain the arterial oxygen saturation percentage measured by pulse oximeter above 90%. Use of oxygen with a high inspiratory oxygen fraction, if needed, the duration of its use should be limited to avoid oxygen poisoning. After 12 hours, high-flow oxygen therapy will be stopped, and if the patients still need oxygen administration, oxygen therapy with a simple face mask with a flow intensity of 5 to 10 liters per minute will continue according to the needs of the patients.
Category
Prevention
2
Description
Control group: In the control group, after the removal of the tracheal tube, the usual oxygen therapy will be carried out continuously through a nasal cannula or a simple face mask with a flow rate of 6 to 10 liters per minute, and the oxygen flow will be adjusted to maintain the oxygen saturation of the patients above 90%.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib (AS) hospital in ZahedanCity
Full name of responsible person
Abdolrab Dorazehi
Street address
Ali Ibn Abi Talib (AS) Hospital, in front of Imam Khomeini Mosque, Persian Gulf Highway, Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۳۱۱۱
Phone
+98 54 3329 5570
Fax
+98 54 1341 1252
Email
hospital.aliebneabitaleb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolrab Dorazehi
Street address
Zahedan Medical Sciences Campus, Imam Hossein Blvd, Dr. Hasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
info@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolrab Dorazehi
Position
Student of Bachler of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13, Infront of Azadi 50, South Azadi Blvd, Iranshahr Town
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914943749
Phone
+98 54 3722 6364
Email
abdoldora1990@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolrab Dorazehi
Position
Student of Master Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13, Infront of Azadi 50, South Azadi Blvd, Iranshahr Town
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914943749
Phone
+98 54 3722 6364
Email
abdoldora1990@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdolrab Dorazehi
Position
Student of Master Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.13, Infront of Azadi 50, South Azadi Blvd, Iranshahr Town
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914943749
Phone
+98 54 3722 6364
Email
abdoldora1990@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the study, data extraction and analysis will be published as an article.
When the data will become available and for how long
After completing the study, data extraction and analysis will be published as an article.
To whom data/document is available
After completing the study, data extraction and analysis will be published as an article.
Under which criteria data/document could be used
After completing the study, data extraction and analysis will be published as an article.
From where data/document is obtainable
After completing the study, data extraction and analysis will be published as an article.
What processes are involved for a request to access data/document
After completing the study, data extraction and analysis will be published as an article.