determination of the effect of patient's head position on endotracheal tube cuff pressure in mechanically ventilated patients
Design
quasi experimental study. Each sample will be used as his / her own control.
Settings and conduct
Samples will be selected from the Amol intensive Care unites.
First, the patient is placed in a position with elevation position of 30 degrees and the head will be in a neutral position, without a rotation. The tube trachea balloon is then connected to a German VBM cuff pressure manometer and the cuff pressure is adjusted to 25 cm H2O. During the process, the monitor does not separate the cuff. Each patient will be placed in 6 positions from the starting position.These positions are: anterior flexion, hyper extension , left lateral flexion, right lateral flexion, left rotation and right rotation. the patient will not return to the starting position after each measurement. Between each change position is distance at least of 5 minutes . Care should be taken during the change of position so that no traction is made in the trachea. When the patient is placed in the position, respiration is performed by end-expiratory ventilatory hold in the range of 4 to 5 seconds, and at the same time, the cuff pressure is measured and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age18-65 years old; oral endoteracheal intubation with Supa tube; mechanical ventilation; Richmond Agitation-Sedation Scale=-5.
Exclusion criteria: tracheostomy; high-frequency oscillatory ventilation; pron position; pregnancy; difficult intubation; neck surgery; 37.5<core temperature<35; BMI>30; contraindication of change position; need to mouth or ETT suctioning
Intervention groups
Patients who have ETT through the mouth and are under mechanical ventilation
Main outcome variables
Endotracheal tube cuff pressure
General information
Reason for update
Acronym
ETT
IRCT registration information
IRCT registration number:IRCT20110705006955N4
Registration date:2018-03-19, 1396/12/28
Registration timing:retrospective
Last update:2018-03-19, 1396/12/28
Update count:0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Roghieh Nazari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 1919
Email address
r.nazari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2017-01-30, 1395/11/11
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2018-01-31, 1396/11/11
Actual recruitment end date
2018-02-20, 1396/12/01
Trial completion date
empty
Scientific title
The effect of patient's head position on endotracheal tube cuff pressure in mechanically ventilated patients
Public title
The effect of patient's head position on endotracheal tube cuff pressure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age18-65 years old
Oral endoteracheal intubation with Supa tube
Mechanical ventilation
Richmond Agitation-Sedation Scale=-5
Exclusion criteria:
Patients have tracheostomy
High-frequency oscillatory ventilation
Pron position
Pregnancy
Difficult intubation
Neck surgery
37.5 < core temperature < 35
Severe obesity BMI>30
contraindication of change position for example : spinal injury
hemodynamic and respiratory instability
need to oropharyngeal or endotracheal suction
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4617188455
Approval date
2017-03-20, 1395/12/30
Ethics committee reference number
IR.MAZUMS.REC.2857
Health conditions studied
1
Description of health condition studied
intubeted patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
cuff pressur
Timepoint
base line and after change the head position(6 points)
Method of measurement
cuff pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Changing the position of the patient's head: First, the patient is placed in the supine position with a 30 degree elevation. This position is the starting position and in this position, the head will be in a neutral position, without a rotation.The cuff pressure will be adjusted to 25 cm. Then the position of the patient's head will be changed to the 6 position stated above, and the cuff pressure will be measured in each position .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hefdah-e-Shahrivar hospital
Full name of responsible person
roghieh nazari
Street address
17-shahrivar street, Amol
City
Amol
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 4001
Email
roghiehnazari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mrs. Alavi
Street address
Mazandaran University of Medical Sciences, Moallem Sq.
City
Sari
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 3325 7230
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Roghieh Nazari
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
،Talebe Amoli street, Amol Nursing school
City
Amol
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Fax
Email
roghiehnazari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Roghieh Nazari
Position
PhD of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amol Nursing school
City
Amol
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Fax
Email
roghiehnazari@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
roghieh Nazari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Taleb e Amoli S. Nursing school
City
Amol
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Email
roghiehnazari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD