Aim of this study is a survey effect of changes in body position on endotracheal tube cuff pressure and intra-abdominal pressure. 60 Patients who admitted to critical care unit and have inclusion criteria include, age above 18 years old, connect to mechanical ventilation at least 24 hours and stable clinical condition are selected. Patients who have abnormality in airway and asynchronize with mechanical ventilation are excluded. At first in supine position endotracheal cuff pressure and intra-abdominal pressure are measured. Then the patients are randomly placed on positions: 30 degree, 45 degree, 30 degree front of mechanical ventilation and 30 degree backward to mechanical ventilation. Endotracheal tube cuff pressure and intra-abdominal pressure are measured after 5 minute pause in each position. Then effect of change position on intra-abdominal pressure and endotracheal cuff pressure are evaluated.
General information
Acronym
Effect of changes in body position on the endotracheal tube cuff pressure and intra-abdominal press
IRCT registration information
IRCT registration number:IRCT201509176481N7
Registration date:2015-10-22, 1394/07/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of change position on endotracheal and intra-abdominal pressure.
Public title
Effect of change position on endotracheal cuff pressure and intra-abdominal pressure.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age above 18 years old; Connection to mechanical ventilation at least 24 hours; Richmond sedation score -3 to -5; and Exclusion criteria: Hemodynamic instability; Body temperature above 38 or below 35 centigrade; Lack of coordination between patient and mechanical ventilation; Abnormal disorder in airway
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, 5km Damghan road, Semnan, Iran.
City
Semnan
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.Semums.Rec.1394.68
Health conditions studied
1
Description of health condition studied
Patients with mechanical ventilation
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
Endotracheal cuff pressure
Timepoint
5 minutes after change position
Method of measurement
Gauge of pressure- cmH2o
Secondary outcomes
1
Description
Intra-abdominal pressure
Timepoint
5 minutes after change position
Method of measurement
column of water- cmH20
Intervention groups
1
Description
Change position of bed to 30 degree, 45 degree and change position of body to front of mechanical ventilation and back to mechanical ventilation apparatus.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Shahrood
Full name of responsible person
Rasool Ashrafi
Street address
Semnan University of Medical Sciences, 5km Damghan road, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidipoor
Street address
Semnan University of Medical Sciences, End of Basij Avenue, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Rasool Ashrafi
Position
Student of MSc.
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5km Damghan road, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 233365190
Fax
Email
r_ashrafi59@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5km Damghan road, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23333354190
Fax
Email
Soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
PhD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, 5km of Damghan road, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4190
Fax
Email
Soli257@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)