Determining the effect of changing the patient's body position on the pressure of the tracheal tube cuff in patients with spontaneous breathing
Design
Single group clinical trial, Target sampling to achieve the desired volume, Sample size 40 people
Settings and conduct
After obtaining the consent of the patient's guardian and explaining the study stages in the special wards of Razi and Nohom day Torbat Heydariyeh hospitals and selecting the samples with the criteria of entering and leaving the study, patients are placed in the supine position lying on the back and head of the bed with an angle of 30 degrees. they take. The cuff of the tracheal tube is connected to the cuff pressure manometer and the pressure is adjusted to 25 cmh2o. After changing the positions to lying on the back with a bed angle of 45 and 30 and lying on the left and right side with a head angle of 30 degrees, the cuff pressure changes Is recorded.
Participants/Inclusion and exclusion criteria
1-conscious consent of the patient's guardian to attend the research
2-Having an endotracheal tube With a High-Volume, Low-Pressure Cuff with an inner diameter of 7 to 8.5 mm and made by Supa
3- Permission of the treating physician to To change position
4- Spontaneous breathing in the normal range
5-Blood pressure in the normal range
6- body Temperature in the normal range
7- No history of respiratory disease
8- Richmond Agitation-Sedation Scale between -3 to -5
9- Do not take Respiratory dilator drug's until one hour before the procedure
Intervention groups
This study has a group on which the body change position in the studied positions is performed on this group and the cuff pressure of the tracheal tube is measured after the change of position.
Main outcome variables
Changing the status of patients under intubation to lying on the right and left sides significantly increases the pressure of the tracheal tube cuff.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200702047984N1
Registration date:2020-07-09, 1399/04/19
Registration timing:retrospective
Last update:2020-07-09, 1399/04/19
Update count:0
Registration date
2020-07-09, 1399/04/19
Registrant information
Name
hossein monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3513
Email address
hoseinmonfared01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-10-23, 1398/08/01
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2020-03-20, 1399/01/01
Scientific title
The effect of changes in body position on patient's endotracheal tube cuff pressure in intubated patients with spontaneous breathing
Public title
The effect of changes in body position on patient's endotracheal tube cuff pressure in intubated patients with spontaneous breathing
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients hospitalized in special wards of Torbat Heydariyeh hospitals
Having an endotracheal tube With a High-Volume, Low-Pressure Cuff with an inner diameter of 7 to 8.5 mm and made by Supa
Richmond Agitation-Sedation Scale between -3 to -5
Exclusion criteria:
The patient's guardian does not consent to continue the procedure
Hemodynamic instability
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
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 gonabad University of Medical Sciences
Street address
Khorasan, Gonabad, Imam Khomeini Avenue, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.GMU.REC.1398.112
Health conditions studied
1
Description of health condition studied
Change of the endotracheal tube cuff pressure While changing the patient's body position In patients with endotracheal tube and spontaneous breathing
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
The patient's tracheal tube cuff pressure
Timepoint
Immediately, 10, 20 and 30 minutes after changing position
Method of measurement
endotracheal cuff Pressure manometer made by VBM ;Germany
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes 40 patients admitted to intensive care units. These patients have a chip tube, breathe spontaneously, and are not connected to a ventilator. The intervention is to change the patient's position from the basic position (lying on the back of the bed at an angle of 30 degrees) to the positions lying on the left and right sides of the head with an angle of 30 degrees and lying on the back with the head at an angle of zero and 45 degrees. The chip tube pressure is recorded immediately, 10, 20, and 30 minutes after the status change.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohom Dey hospital
Full name of responsible person
Dr.Hossein َََAzizi
Street address
Kashani Ave, Nohom dey Hospital
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
3116695188
Phone
+98 51 5222 6020
Email
PR@thums.ac.ir
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Amir Eslamian
Street address
Emam reza Ave, Razi Hospital
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9519654145
Phone
+98 51 5223 5012
Email
hosp@razihosp.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Jalal Mardaneh
Street address
Emam Khomeyni Ave., Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Monfared
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Ave, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
hoseinmonfared01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Monfared
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Ave, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
hoseinmonfared01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Monfared
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Ave, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
hoseinmonfared01@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period after printing the results