The aim of this study was to evaluate the effect of endotracheal suctioning 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 units.
A trained nurse assistant will work on data collection, and data will be collected between 8 AM and 8 PM. At this stage, there will be no aggressive intervention or a change position of the patient.If necessary, the patient will be excluded from the above interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-65 years old, orotrachal intubation, mechanical ventilation.
Exclution criteria: tracheostomy, high-frequency oscillatory ventilation, pron position
Intervention groups
experimental group:At first, the cuff pressure of patients who have ETT through the mouth and are under mechanical ventilation, will be measured and set on 22 centimeters H2O. Then the patient will be suctioned with open method and the cuff pressure will be measured during suctioning and at 15, 30 and 60 minutes intervals.
control group: At first, the cuff pressure of patients who have ETT through the mouth and are under mechanical ventilation, will be measured and set on 22 centimeters H2O. Then the cuff pressure will be measured at 15, 30 and 60 minutes intervals.
Main outcome variables
Endotracheal tube cuff pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110705006955N5
Registration date:2018-06-29, 1397/04/08
Registration timing:retrospective
Last update:2018-06-29, 1397/04/08
Update count:0
Registration date
2018-06-29, 1397/04/08
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
2017-05-22, 1396/03/01
Expected recruitment end date
2018-03-03, 1396/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endotracheal suctioning on endotracheal tube cuff pressure in mechanically ventilated patients
Public title
Effect of suction on cuff pressure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age18-65 years old
Oral endoteracheal intubation
mechanical ventilation
Exclusion criteria:
Tracheostomy
High-frequency oscillatory ventilation
Pron position
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:
61
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
2017-05-05, 1396/02/15
Ethics committee reference number
IR-MAZUMS.REC.2838
Health conditions studied
1
Description of health condition studied
intubeted patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
endoteracheal tube cuff pressure
Timepoint
no suctioning, 15,30 and 60 minuts after suction
Method of measurement
cuff pressur monitoring
Secondary outcomes
empty
Intervention groups
1
Description
endotracheal suctioning: in this study, open method were used for endotracheal suctioning. in this method, it is necessary to open the respiratory circuit by disconnecting the mechanical ventilator from the ventilatory prosthesis, followed by suctioning with a single-use, strile catheter during 10-15 sec.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hefdah-e-Shahrivar Hospital
Full name of responsible person
Roghieh Nazari
Street address
Hefdah-e-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 Science
Full name of responsible person
Dr. Majeed Saeedi
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 Science
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Talebe Amoli ُtreet, Amol Nursing ُchool
City
Amol
Province
Mazandaran
Postal code
4615861467
Phone
+98 11 4422 1919
Fax
Email
r.nazari@mazums.ac.ir
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
Assistant Professor
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
r.nazari@mazums.ac.ir
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