Aim of this study is a survey effect of changes in body position and head of bed on endotracheal tube cuff pressure in patient hospitalized in intensive care unit. 29 Patients who admitted to critical care unit and have inclusion criteria include, Age above 18 years old; Oral Endotracheal tube, Richmond sedation score -3 to -5; receiving mechanical ventilation for more than 24 hour and less than a week; systolic blood pressure more than 90 mm Hg and normal tempreture are selected.
First the patients will be placed in a neutral position (30° angle to the head of the bed and head towards the body) for initiating data collection. Then the patient's position will change in each half hours sequence determined by researcher; left lateral position with a 30° angle to the head of the bed and head towards the body, right lateral position with a 30° angle to the head of the bed and head towards the body, left lateral position with 45° angle to the head of the bed and head towards the body, right lateral position with a 45° angle to the head of the bed and head towards the body. In each patient's change position, endotracheal tube cuff pressure will measure and record immediately before and after change position,and after 10 minutes .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051817735N1
Registration date:2016-04-15, 1395/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-15, 1395/01/27
Registrant information
Name
Mehdi Miri
Name of organization / entity
Torbat-e- Heydarieh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 1222 8020
Email address
mirim1@thums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of body position Change on the endotracheal tube cuff pressure in patient hospitalized in intensive care unit.
Public title
The effect of body Change position on the endotracheal tube cuff pressure.
Purpose
Prevention
Inclusion/Exclusion criteria
Participant: the subjects included in the study were above 18 years old with oral endotracheal tube whose Richmond sedation score were between 3-5. They had received mechanical ventilation for less than a week, had normal body tempreture and their systolic blood pressure were above 90 mmHg.
Those whose endotracheal cuff tube pressure rised above 50 mmHg for more than half an hour after the intervention were subject to exclusion.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
29
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
Sabzevar University of Medical Sciences
Street address
Asad Abadi st.
City
Sabzevar
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IRCT.MEDSAB.REC.1394.37
Health conditions studied
1
Description of health condition studied
acute respiratory failure
ICD-10 code
J96.0
ICD-10 code description
acute respiratory failure
Primary outcomes
1
Description
cuff pressure
Timepoint
Befor intervention, immediately after intervention
Method of measurement
Pressure is controlled by a mercury manometer according mm Hg .
Secondary outcomes
empty
Intervention groups
1
Description
Through the first intervention after the first subjects were positioned in a basic position lying on a bed declined about 30 degree with head aligned the body.
Then the endotracheal cuff tube pressure is measured with a standard manometer in therm of mmHg.
If needed the subjects’ condition will be studied based on different positions subjects will take ( lying on the left with head aligned the body on a bed in 30 degree position, lying on the right with head aligned the body again on a bed in 30 degree position, being semi setting on a bed in 45 degree with head aligned the body, and finally lying on the left and right respectively on a bed in 45 degree position with head aligned the body ). The cuff tube pressure is measured each time. The subjects’ position is change instantly before and after the change.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
9 Day Hospital
Full name of responsible person
Mehdi Miri
Street address
Parastar st.
City
Torbat-e-Heydarie
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohamad Mohamadzade
Street address
Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mehdi Miri
Position
Student of MSc.
Other areas of specialty/work
Street address
Asad Abadi st.
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
MEHDI.MIRI11@YAHOO.COM MIRIM1@THUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Estaji
Position
MSc
Other areas of specialty/work
Street address
Asad Abadi st.
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4401 1000
Fax
Email
z.estaji@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mehdi Miri
Position
Clinical Nurse Spacialist student
Other areas of specialty/work
Street address
Asad abadi st.
City
Sabzevar
Postal code
Phone
+98 51 4401 1000
Fax
Email
MEHDI.MIRI11@YAHOO.COM MIRIM1@THUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)