Evaluation of pressure- and volume-controlled ventilation on internal jugular vein collapsibility index as a predictor of fluid responsiveness in hypovolemic mechanically ventilated patients in intensive care unit.
Evaluation of pressure- and volume-controlled ventilation on internal jugular vein collapsibility index as a predictor of fluid responsiveness in hypovolemic mechanically ventilated patients in intensive care unit.
Design
60 patients will be included in this double blind clinical trial. Patients will be randomly divided into two groups. The set of ventilators will be changed by a personnel and the internal jugular vein collapsibility index will be measured by another one. In this study, trial phase is not applicable.
Settings and conduct
This study will be conducted on patients underwent mechanical ventilation in intensive care units.The patients will be allocated to 1 of the 2 groups according to a randomization code list in a computer program. Patients and researchers are not aware of the treatment group. Patients are not aware of the treatment group due to the decreased level of consciousness. A person will change the set of ventilators and one another will measure the internal jugular vein collapsibility index.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hypovolymic patients; aged over 18 years. Exclusion criteria: Cardiovascular and pulmonary disease; Cervical collar or neck dressing; Internal jugular collapsibility index less than 18%
Intervention groups
Hypovolymic patients will be divided into two groups. patients in the first group will be placed on the volume-controlled ventilation and in the second group will be placed on the pressure-controlled ventilation. The internal jugular colapsibility index will be measured before and after fluid therapy.
Main outcome variables
Internal jugular vein collapsibility index in pressure- and volume-controlled ventilation before and after fluid therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005363N12
Registration date:2019-04-29, 1398/02/09
Registration timing:registered_while_recruiting
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pressure- and volume-controlled ventilation on internal jugular vein collapsibility index as a predictor of fluid responsiveness in hypovolemic mechanically ventilated patients in intensive care unit.
Public title
Evaluation of pressure- and volume-controlled ventilation on internal jugular vein collapsibility index in hypovolemic patients.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Hypovolemic patients
Age over 18 years
Exclusion criteria:
Cardiovascular and pulmonary diseases
Sepsis
Neck collar or neck dressing
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Internal jugular colposibilty index is measured before and after fluid therapy in each patient.
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be allocated to 1 of the 2 groups according to a randomization code list by a computer program.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are not aware of the treatment group due to the decreased level of consciousness. The researcher who studies the variables, does not know the group of study and change of ventilator setting is done by another person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513994945
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.ZUMS.REC.1396.179
Health conditions studied
1
Description of health condition studied
Hypovolemia
ICD-10 code
E86.1
ICD-10 code description
Hypovolemia
Primary outcomes
1
Description
Internal jugular collapsibility index in volume mode before fluid therapy
Timepoint
5 minutes after selecting the volume mode
Method of measurement
ultrasound system (eZono 3000)
2
Description
Internal jugular collapsibility index in pressure mode before fluid therapy
Timepoint
5 minutes after selecting the pressure mode
Method of measurement
ultrasound system (eZono 3000)
3
Description
Internal jugular collapsibility index in volume mode after fluid therapy
Timepoint
5 minutes after fluid therapy
Method of measurement
ultrasound system (eZono 3000)
4
Description
Internal jugular collapsibility index in pressure mode after fluid therapy.
Timepoint
5 minutes after fluid therapy
Method of measurement
ultrasound system (eZono 3000)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients will be placed on the ventilator under the following conditions. CMV: TV= 8 cc/Kg, PEEP=5, Fio2=50%, and the internal jugular colapsibility index will be measured before and after fluid therapy.
Category
Diagnosis
2
Description
Intervention group: The patients will be placed on the ventilator under the following conditions. PCV and inspiratory pressure will be adjusted so that the tidal volume will be kept at 8 cc / Kg and the current volume does not exceed 900 Cc and the maximum pressure will be less than 30 centimeters of water.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi Hospital
Full name of responsible person
Taraneh Naghibi
Street address
Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3313 1559
Email
tnaghibi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza shoghli
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
sajad Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Gavazang Road, Mosavie Hospital
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3313 1559
Email
sajad.mohammadi.6182@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Naghibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mosavi Hospital, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 243313559
Email
tnaghibi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Naghibi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mosavi Hospital, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24 3313 1559
Email
tnaghibi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available