Evaluating the effect of adding acetazolamide to routine regimen on respiratory parameters of mechanically ventilated patients in the intensive care unit
The effect of acetazolamide on respiratory parameters of patients connected to a ventilator in intensive care unit
Design
This study is conducted as a clinical trial with a control group and an intervention group, in a triple-blind manner, with random allocation through block randomization method, phase 3 on 30 patients.
Settings and conduct
This study is performed in the ICU of Shahid Yahya Nejad Hospital in Babol. Neither patients nor staff are aware of the type of intervention, and both groups receive routine care. The researcher will measure respiratory parameters in both groups half an hour before and 2 hours after taking acetazolamide.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients should be connected to a ventilator; Patients diagnosed with non-traumatic diseases (absence of trauma, especially trauma to the head and chest)، Age over 18 years old (adults).
Exclusion criteria: Hemodynamic instability (patients during heart shock and severe cardiovascular disorders, patients with brain death, patients in need of pacemakers, patients with renal failure, etc.); Having metabolic acidosis in the ABG test.
Intervention groups
Intervention group: Patients will receive acetazolamide in addition to routine care. Control group: they will receive only routine care.
Main outcome variables
Respiratory rate, Tidal volume, Percentage of hemoglobin with oxygen (SPO2)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210707051809N1
Registration date:2022-07-18, 1401/04/27
Registration timing:prospective
Last update:2022-07-18, 1401/04/27
Update count:0
Registration date
2022-07-18, 1401/04/27
Registrant information
Name
behnam esbakian bandpey
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3272 2788
Email address
behnam.esbakian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of adding acetazolamide to routine regimen on respiratory parameters of mechanically ventilated patients in the intensive care unit
Public title
The effect of acetazolamide on respiratory parameters of mechanically ventilated patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be connected to a ventilator
Patients diagnosed with non-traumatic illness (absence of trauma, especially head and chest trauma)
Age over 18 years old
Exclusion criteria:
Hemodynamic instability (patients during heart shock and severe cardiovascular disorders, patients with brain death, patients in need of pacemakers, patients with renal failure, etc.)
Presence of metabolic acidosis in the ABG test
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The study samples will be randomly assigned to two intervention and control groups (blocked) using the two-way block method, which will be the intervention group (A) and the control group (B). AA, BB, BA, AB state will be created and these states will be written on separate cards, and the doctor will take out the patient card from the bag randomly for fifteen separate times and will write these states in order. For example, if the first card is AB, it means that the first patient is part of the intervention group and the second patient is in the control group, and sampling is done randomly until the states are finished.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patients and the clinical caregivers and the data analyzer are not aware of the study method
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences; Ganj Afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2021-07-09, 1400/04/18
Ethics committee reference number
IR.MUBABOL.REC.1400.094
Health conditions studied
1
Description of health condition studied
Patients connected to a ventilator
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Respiratory rate
Timepoint
Four times a day (morning, once before and once after) - (evening, once before and once after) and for 3 consecutive days
Method of measurement
Cardiopulmonary monitoring device and ventilator device
2
Description
Tidal volume
Timepoint
Four times a day (morning, once before and once after) - (evening, once before and once after) and for 3 consecutive days
Method of measurement
Cardiopulmonary monitoring device and ventilator device
3
Description
Percentage of hemoglobin saturated with oxygen
Timepoint
Four times a day (morning, once before and once after) - (evening, once before and once after) and for 3 consecutive days
Method of measurement
Cardiopulmonary monitoring device and ventilator device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients connected to a ventilator who, in addition to routine care, take acetazolamide tablets. Acetazolamide 250 mg tablets are administered orally (gavage) twice daily for 3 consecutive days.
Category
Treatment - Drugs
2
Description
Control group: Patients connected to a ventilator who receive only routine care and do not take acetazolamide tablets
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nejad Hospital of Babol
Full name of responsible person
Behnam Esbakian Bandpey
Street address
Yahya Nejad Hospital; Mostafa Khomeini Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3222 3594
Email
BEHNAM.ESBAKIAN@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Behnam Esbakian Bandpey
Street address
Babol University of Medical Sciences; Ganj Afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
BEHNAM.ESBAKIAN@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Behnam Esbakian Bandpey
Position
Instructor of Paramedical School
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Babol University of Medical Sciences; Ganj Afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
BEHNAM.ESBAKIAN@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Behnam Esbakian Bandpey
Position
Instructor of Paramedical School
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Babol University of Medical Sciences; Ganj Afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
BEHNAM.ESBAKIAN@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Behnam Esbakian Bandpey
Position
Instructor of Paramedical School
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Babol University of Medical Sciences; Ganj Afrooz Street
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
behnam.esbakian@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
Not applicable
Title and more details about the data/document
After the end of the study and data analysis, the results and data, including the study protocol, statistical analysis map, clinical study report, after removing the confidential information, will be available to all people who want to access and use this study.
When the data will become available and for how long
2023
To whom data/document is available
Everyone
Under which criteria data/document could be used
Access is free
From where data/document is obtainable
behnam.esbakian@gmail.com
What processes are involved for a request to access data/document