Evaluation of the effect of positive end expiratory pressure on internal jugular vein collapsibility index in mechanically ventilated patients in intensive care unit.
Evaluation of the three different positive end expiratory positive pressure effect on internal jugular vein collapsibility index in mechanically ventilated patients
Design
30 patients will be included in this double blind clinical trial. A person will change the set of ventilators and one another will measure the internal jugular vein collapsibility index. In this study, randomization and trial phase is not applicable.All patients are in one group.Ventilator changes is applied three times in each patient.
Settings and conduct
This study is done on 30 patients over 18 years of age and connect to ventilator. All patients are in one group and end expiratory positive pressure of ventilator changes with 0, 5 and 10 cm H2O will be applied three times in each patient.This study is a double blind clinical trial. A person will change the set of ventilators and one another will measure the internal jugular vein collapsibility index. In this study, randomization and trial phase is not applicable.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years. Exclusion criteria: Cardiovascular and pulmonary disease; Cervical collar or neck dressing
Intervention groups
Patients are placed on three end expiratory positive pressure of 0, 5 and 10 cm H2O. Internal jugular collapsibility index is measured in all three tidal volumes. After the fluid therapy , the above steps will be repeated and ventilator changes is applied three times before and after fluid therapy in each patient.
Main outcome variables
Internal jugular vein collapsibility index in end expiratory positive pressure of 0, 5 and 10 cm H2O
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005363N13
Registration date:2019-06-13, 1398/03/23
Registration timing:registered_while_recruiting
Last update:2019-06-13, 1398/03/23
Update count:0
Registration date
2019-06-13, 1398/03/23
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
2019-05-10, 1398/02/20
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of positive end expiratory pressure on internal jugular vein collapsibility index in mechanically ventilated patients in intensive care unit.
Public title
The effect of positive end expiratory pressure on internal jugular vein collapsibility index
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
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:
30
More than 1 sample in each individual
Number of samples in each individual:
3
Internal jugular vein collapsibility index in various positive end expiratory pressure
Randomization (investigator's opinion)
N/A
Randomization description
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 intervention and change of ventilator setting is done by another person.
Placebo
Not used
Assignment
Single
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
2019-05-08, 1398/02/18
Ethics committee reference number
IR.ZUMS.REC.1398.025
Health conditions studied
1
Description of health condition studied
Evaluation of internal jugular vein collapsibility index in three different of positive end expiratory pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Internal jugular collapsibility index in positive end expiratory pressure of 0 cm H2O
Timepoint
5 minutes after selecting the positive end expiratory pressure of 0 cm H2O
Method of measurement
ultrasound system (eZono 3000)
2
Description
Internal jugular collapsibility index in positive end expiratory pressure of 5 cm H2O
Timepoint
5 minutes after selecting the positive end expiratory pressure of 5 cm H2O
Method of measurement
ultrasound system (eZono 3000)
3
Description
Internal jugular collapsibility index in positive end expiratory pressure of 10 cm H2O
Timepoint
5 minutes after selecting the positive end expiratory pressure of 10 cm H2O
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. SIMV: TV= 8 cc/Kg, RR=10, PEEP=0, Fio2=50%. Then positive end expiratory pressure of ventilator will be changed to 5 and 10 cm H2O and the internal jugular colapsibility index will be measured after each conditions.
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 Ali Reza 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
Hamid Kafili
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Mosavi Hospital, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4513994945
Phone
+98 24833131559
Email
hkafili55@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 24 3313 1559
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
Zanian
Province
Zanjan
Postal code
4513994945
Phone
+98 24833131559
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