Protocol summary

Summary
This study is evaluated the impact of changes body position on bladder pressure that can show intra-abdominal pressuer measurement . each study participant is bladder pressure measured three separate times at each of the three positions (supine or zero,15,30 degree ). IAP is measured using korn technique with a instillation 20 ml normal salin into patient of bladder. the transduser is zeroed at the level of the symphsis pubis in each patient , the least 1 min is allowed for equilibration of IAP with each reading.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010214787N2
Registration date: 2011-11-05, 1390/08/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-11-05, 1390/08/14
Registrant information
Name
Tahereh Khaleghdoost Mohammadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5058
Email address
khaleghdoost@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Guilan University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra-abdominal pressure in position degrees at zero ,15 and 30 head of bed in intensive care units admited patients at educational –thraputic centers in Rasht, 1390
Public title
Measuring intra -abdomen pressure in intensive care units patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18; admission duration in ICU less than 24 hours, being connected to ventilator for the last 24 hours; indwelling bladder catheter placed with NGT and RASS score equal or less than 4. Exclusion criteria: pregnancy; pelvic fracture, hematoma; previous cystectomy; traumatic bladder rupture and hemodynamic instability
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
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
Guilan University of Medical Sciences Ethics committee
Street address
Guilan University of Medical Sciences
City
Rasht
Postal code
65385-41446
Approval date
2011-10-04, 1390/07/12
Ethics committee reference number
290963812

Health conditions studied

1

Description of health condition studied
Intra-abdominal pressure
ICD-10 code
K91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified

Primary outcomes

1

Description
Intra-abdomen pressure
Timepoint
Every 8 hours
Method of measurement
Manometer

Secondary outcomes

empty

Intervention groups

1

Description
One group-measuring intra-abdominal pressure in three zero,15 and 30 degree head of bed
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
Porsina Hospital
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Street address
Namjo street- Porsina Hospital
City
Rasht

2

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Tahereh khaleghdoost Mohammadi
Street address
Razi Hospital, Sardar Jangel street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasool Sobhani
Street address
Vice-Chancellor for Research Namjo st.,
City
Rasht
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Sadigheh Samimiyan
Position
MS of Critical care student (MSc)
Other areas of specialty/work
Street address
Rasht-Gilan-Iran
City
Rasht
Postal code
Phone
+98 13 1322 2444
Fax
Email
s.samimian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
MS in Nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Postal code
41469
Phone
+98 13 1555 5056
Fax
Email
khaleghdoost@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
MS in nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Postal code
41469
Phone
+98 13 1555 5056
Fax
Email
khaleghdoost@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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