The Relationship Between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients admitted to intensive care units
Determine the relationship between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients admitted to intensive care units
Design
Before and After clinical trial
Settings and conduct
This study will be done among mechanically ventilated patients admitted to intensive care units in Imam Khomeini teaching hospital in Urmia.
Intra Abdominal pressure will measured by Intra Vesical Pressure measurment by central venuse presure measurment manometer.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age > 18 years old
Mechanically ventilated patient
Have indwelling urine catheter in place
Score of Critical care Pain Observation Tool ≤2
Length of ICU stays ≥ 48 hours;
Exclusion Criteria:Unable to change position
Norogenic bladder
Bladder rupture
Hematuria
Heart failure and Pulmonary edema
Pregnancy
Excessive obesity
Acute abdominal patients
Probability of survival less than 24 hours
Intervention groups
We will measure the Intra Abdominal Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.Then each patient will be compared with him/herself in each different situations.
Main outcome variables
Intra Abdominal Pressure; Mean Arterial Pressure; Abdominal Perfusion Pressure; Mean Airway Pressure; Peak Inspiratory Pressure؛ Plateau Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181105041560N1
Registration date:2019-02-19, 1397/11/30
Registration timing:registered_while_recruiting
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Yusef Haghighi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
hagigym@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-17, 1397/11/28
Expected recruitment end date
2019-04-17, 1398/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Relationship Between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients admitted to intensive care units
Public title
The Relationship Between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years old
Mechanically ventilated patient
Have indwelling urine catheter in place
Scor of Critical care Pain Observation Tool ≤2
Length of ICU stays ≥ 48 hours
Exclusion criteria:
Unable to change position
Norogenic bladder
Bladder rupture
Hematuria
Heart failure and Pulmonary edema
Pregnancy
Excessive obesity
Acute abdominal patients
Probability of survival less than 24 hours
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Next to the Emergency department., Jahad Ave., Resalat Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.UMSU.REC.1397.358
Health conditions studied
1
Description of health condition studied
Intra Abdominal Presure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intra Abdominal Pressure:The intra-abdominal pressure is a sustained pressure that lies inside the abdominal cavity.
Timepoint
we will Measure inetra abdominal pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
Measuring Intera-vesical pressure by water manometer of central vein pressure measuring device.
Secondary outcomes
1
Description
Mean Arterial Pressure: It is the average amount of the systemic pressure with normal range of 70 to 105 mm Hg.
Timepoint
we will Measure the Mean Arterial Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
It will be measured by a monitor device attached to the patient
2
Description
Abdominal Perfusion Pressure:If the intra-abdominal pressure is lowered from the median arterial pressure, abdominal perfusion pressure will be obtained. In adults, it should be above 50 mm Hg to provide adequate ventricular perfusion.
Timepoint
we will measure Abdominal Perfusion Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
we will Calculate the Abdominal Perfusion Pressure with subtraction the mean arterial pressure measured by the monitor attached to the patient and intera abdominal pressure measured by water manometer.
3
Description
Mean Airway Pressure:It is the pressure measured at the airway opening, averaged over the entire ventilatory cycle.
Timepoint
we will measure the Mean Airway Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
It will be measured by the ventilator device attached to the patient.
4
Description
Peak Inspiratory Pressure:It is the highest level of pressure applied to the lungs during inhalation.
Timepoint
we will measure the Peak Inspiratory Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
It will be measured by the ventilator device attached to the patient.
5
Description
Plateau Pressure:It is the pressure of the air ways at the end of inspration.
Timepoint
we will measure the Plateau Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
It will be measured by the ventilator device attached to the patient.
6
Description
Auto PEEP: The Positive End Expratory Pressure in the air ways that is becouse of inadequate expratory tim.
Timepoint
we will measure the Auto PEEP in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours.
Method of measurement
It will be measured by the ventilator device attached to the patient.
Intervention groups
1
Description
Control group: This study is an interventional study of the type before and after.In such a way that each person in different states of the body will be used as a witness for himself.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia, Imam Khomeini teaching hospital
Full name of responsible person
Ali Akbar Nasiri
Street address
Ershad Ave., Aiat Allah Modarres Blvd., Imam Khomeini teaching hospital
City
Urmia
Province
West Azarbaijan
Postal code
57157-81351
Phone
+98 44 3346 9931
Email
Nasiriali7@gmail.com
Web page address
https://imam.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Next to the Emergency department., Jahad Ave., Resalat Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
irajmohebbi@umsu.ac.ir
Web page address
https://research.umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Yusef Haghighi moghadam
Position
PhD in Nursing, Assistant professor Faculty of Nursing & Midwifery School, urmia University of Medic
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
hagigym@yahoo.com
Web page address
https://nm.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yusef Haghighi moghadam
Position
PhD in Nursing, Assistant professor Faculty of Nursing & Midwifery School, urmia University of Medic
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
hagigym@yahoo.com
Web page address
https://nm.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yusef Haghighi moghadam
Position
PhD in Nursing, Assistant professor Faculty of Nursing & Midwifery School, urmia University of Medic
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pardis Nazloo
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
hagigym@yahoo.com
Web page address
https://nm.umsu.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