Investigating the effect of changes in the positive end-expiratory pressure on central venous pressure
Design
Semi-experimental clinical trial.
Patients over 18 years of age with CV line who are under mechanical respiration and have stable vital signs will enter the study.
The number of samples will be based on the coefficient correlation sample size formula equal to 62 which increased to 70 to guarantee.
The sampling method of this study is consecutive.
Randomization won't be used
Settings and conduct
This study will be done at Intensive care unit of Poursina hospital in Rasht.
In addition, the study will be performed double blind in which all measurements will be done by one person (emergency medicine resident) who is not involved in the study and is not aware of PEEP's condition. Meanwhile, patients won’t be aware of the events due to intubation and receiving anesthesia drugs.
Participants/Inclusion and exclusion criteria
Inclusion criterion:
All patients over 18years of age admitted with CV line and stable vital signs.
Non-inclusion Criteria:
Patients need to receive more than 200mL of fluid per hour;
Patients with auto PEEP;
Patients need PEEP more than 10cmH2O;
The dissatisfaction of first-degree relatives of the patient;
Any contraindications to increase PEEP.
Intervention groups
There is only one intervention group. Intubated patients connected to a ventilator who have a right subclavian vein catheter with one type of sedation drug and one type of ventilator settings have entered the study. Central venous pressure (CVP) in peep 3, 5 and 7 will be measured with a CVP ruler by one person (emergency medicine resident who is not in the study and does not know the peep number (for blinding)).
Main outcome variables
Central venous pressure (CVP) in different PEEPs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191211045700N1
Registration date:2020-08-05, 1399/05/15
Registration timing:retrospective
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
mahdi zia ziabari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3322 2444
Email address
drziabari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive end expiratory pressure (PEEP) changes on central venous pressure in hospitalized patients in Intensive care unit
Public title
The effect of positive end expiratory pressure (PEEP) changes on central venous pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18 years and over
Intubated patients connected to the ventilator
Patients with right subclavian CV line
Stable vital sign
Exclusion criteria:
Patients who need more than 200 cc serum per hour
Patients with auto peep
Patients who need more than 10 cmH2O peep
Sudden changes in vital sign with peep change
lung injury
Chronic obstructive pulmonary diseases (COPD)
Asthma
Valve disorders
Acute respiratory distress syndrome (ARDS)
BMI>30
Dissatisfaction of relatives
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Supervisor has no information about peep and just measures CVP.
Patients are not aware of the events due to intubation and receiving anesthesia drugs.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
2008-7284
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.GUMS.REC.1398.320
Health conditions studied
1
Description of health condition studied
Patients who are over 18 years old with CV line, and are under mechanical respiration with stable vital signs and are hospitalized in ICU ward of Poursina Hospital in Rasht. Patients with various diseases such as trauma, CVA, sepsis and ... are hospitalized in this ward.
ICD-10 code
Z99.11
ICD-10 code description
Dependence on respirator [ventilator] status
Primary outcomes
1
Description
Central venous pressure (CVP)
Timepoint
After 10 minutes being on peep 3, 5 and 7
Method of measurement
CV line
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intubated patients connected to a ventilator with one type of sedation drug and one type of ventilator settings will enter the study. Patient demographics will be recorded in pre-designed checklists. To reduce the incidence of error, patients with a right subclavian vein catheter will be included in the study.Patients' CVP will be measured after ten minutes in peep 3, 5, 7. Then the CVP number and its changes in the three measured pipes (3, 5 and 7) will be recorded in the checklists.Also, all measurements will be performed by one person (emergency medicine resident who is not in the study and does not know Peep status (for blindness)) and at the level of par with the sternum angle and with a special CVP ruler. Then the changes of CVP in different pipes (peep from 3 to 5, 5 to 7 and also 3 to 7) will be examined and will be analyzed by statistical tests.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina hospital
Full name of responsible person
Seyyed Mahdi Zia Ziabari
Street address
Poursina hospital, Namjoo street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Email
poursina_pr@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Zia Ziabari
Street address
Poursina hospital, Namjoo street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Email
poursina_pr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Zia Ziabari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Poursina hospital, Poursina intersection
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 9842
Email
drziabari@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Zia Ziabari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Poursina hospital, Poursina Intersection
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 9842
Email
drziabari@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Zia Ziabari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Porsina hospital, poursina Intersection
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 9842
Email
drziabari@gums.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
The data about the main outcome will be given to the applicants after deleting the patients' personal information in SPSS file format.
When the data will become available and for how long
Three months after finishing of study.
To whom data/document is available
The researchers in medical centers
Under which criteria data/document could be used
To compare with other studies and also for estimating sample size.
From where data/document is obtainable
To receive more information, be in contact with Dr. Seyed Mehdi Zia Ziaberi via drziabari@gums.ac.ir mail address.
What processes are involved for a request to access data/document
A request letter and information related to researcher including his/her ID card would send them to the mentioned e-mail address. The information will be sent within 15 days after receiving the request.