Comparison of the effects of two modalities of adaptive support ventilation and pressure-related volume control in terms of changes in heart rate and blood pressure and duration of separation from mechanical ventilation in patients admitted to the intensive care unit
Evaluation of the effects of two modalities of adaptive support ventilation and pressure-related volume control in terms of changes in heart rate and blood pressure and duration of separation from mechanical ventilation in patients admitted to the intensive care unit
Design
Clinical trial with control group with parallel, randomized groups, phase 3 on 74patients. The random number table was used for randomization
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients are randomly divided into two groups. The first group is treated with adaptive support ventilation modality by the ventilator and the second group is even treated with pressure-related volume control modality by the ventilator. Patients will be examined by physicians for changes in heart rate, blood pressure, and duration of separation from the mechanical ventilator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients 18-70 years old admitted to the intensive care unit, requiring mechanical ventilation, ability to perform both modalities for patients and having informed consent of co-patients to participate in the study. Exclusion criteria: Chronic lung disease prior to study, multiple organ failure at admission
Intervention groups
Intervention group: Patients in this group are treated with adaptive support ventilation modality by a ventilator. Patients will be examined by physicians for changes in heart rate, blood pressure, and duration of separation from the mechanical ventilator. Control group: Patients in this group are treated with pressure-related volume control modality by a ventilator. Patients will be examined by physicians for changes in heart rate, blood pressure, and duration of separation from the mechanical ventilator.
Main outcome variables
Heart rate changes, Blood pressure changes, Duration of separation from the mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022681N3
Registration date:2020-08-06, 1399/05/16
Registration timing:registered_while_recruiting
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 195 1374
Email address
alikiaiib@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-25, 1399/05/04
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two modalities of adaptive support ventilation and pressure-related volume control in terms of changes in heart rate and blood pressure and duration of separation from mechanical ventilation in patients admitted to the intensive care unit
Public title
Effects of two modalities of adaptive support ventilation and pressure-related volume control in terms of changes in heart rate and blood pressure and duration of separation from mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in the intensive care unit
Requiring mechanical ventilation
Age 18 to 70 years
Ability to perform both modalities for patients
Having informed consent of co-patients to participate in the study
Exclusion criteria:
Previous Chronic lung disease
Multi-organ failure at admission
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.MUI.MED.REC.1398.155
Health conditions studied
1
Description of health condition studied
Hospitalized in the intensive care unit and requiring mechanical ventilation
ICD-10 code
R06.81
ICD-10 code description
Apnea, not elsewhere classified
Primary outcomes
1
Description
Heart rate changes
Timepoint
Every hour until the first 6 hours and then from 6 hours to 24 hours and then daily
Method of measurement
By ECG
2
Description
Blood pressure changes
Timepoint
Every hour until the first 6 hours and then from 6 hours to 24 hours and then daily
Method of measurement
By sphygmomanometer
3
Description
Duration of separation from the mechanical ventilation
Timepoint
Every hour until the first 6 hours and then from 6 hours to 24 hours and then daily
Method of measurement
By checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group are treated with adaptive support ventilation modality by a ventilator. Patients will be examined by physicians for changes in heart rate, blood pressure, and duration of separation from the mechanical ventilator.
Category
Treatment - Devices
2
Description
Control group: Patients in this group are treated with pressure-related volume control modality by a ventilator. Patients will be examined by physicians for changes in heart rate, blood pressure, and duration of separation from the mechanical ventilator.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Babak Alikiaii
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
alikiaiib@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
alikiaiib@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
alikiaiib@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
alikiaiib@med.mui.ac.ir
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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.