Effect of assessment of the readiness of weaning of head trauma patients from mechanical ventilation device on the duration of mechanical ventilation and duration of hospitalization
Determining the effect of using the weaning tool on the duration of mechanical ventilation and duration of hospitalization.
Design
In this study, 60 patients admitted to the ICU ward, who have had mechanical ventilation for more than 48 hours and have criteria for entering the study, selected by easy sampling and divided into two groups of control and intervention using a 4-block method.
Settings and conduct
This study is a randomized controlled clinical trial. After approval by Ethics Committee and taking informed consent from patients' family, the study begin.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients with head injuries
-At least 18 years old
- Patients under mechanical ventilation for more than 48 hours and less than 2 weeks
- Not having heart disease and other underlying disease
- GCS above 9
Exclusion criteria:
-Spontaneous removal of tracheal tube during the study
-Surgery during the study
-Transferring the patient to other wards
-Having a failure history in weaning
Intervention groups
In the control group, the patient is weaning from the mechanical ventilation device according to the ward routine and the gradual reduction of the number of ventilator breathing and insertion of the patient into the spont mode, is done.In the intervention group, under ventilation patients will be scored based on Persian weaning tool in each shift (q 8 hr.), this score ranks between 26 to 75, If patients get a score of 57 and above, process of weaning will begin under observation of an anesthesiologist and patient is placed on the t-piece.
Effect of assessment of the readiness of weaning of head trauma patients from mechanical ventilation device on the duration of mechanical ventilation and duration of hospitalization
Public title
The effect of evaluation of weaning preparation from ventilator on duration of hospitalization and duration of mechanical ventilation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who were under mechanical ventilation for more than 48 hours
Exclusion criteria:
Patients without an endotracheal tube
Age
From 18 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)
Randomized
Randomization description
Patients will be controlled and intervened by randomization 4-way blocking method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Performing a type of intervention on the test group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-12-01, 1396/09/10
Ethics committee reference number
14002724
Health conditions studied
1
Description of health condition studied
Head traumatic patients undergoing mechanical ventilation
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Duration of mechanical ventilation and duration of hospitalization
Timepoint
48 hours after the extubation
Method of measurement
Persian weaning Tool
Secondary outcomes
1
Description
Hospital costs
Timepoint
After the patient's discharge
Method of measurement
Calculate direct patient costs
Intervention groups
1
Description
Intervention group:Patients with mechanical ventilation over 48 hours who received the criteria for entry with a Persian weaning tool. If they get 57, the patient will be weaning from the mechanical ventilation device. If it can be breathable with T-piece for 2 hours, the weaning will be successful and these patients will be compared with the control group according to the number of mechanical ventilation days and hospitalization duration.
Category
N/A
2
Description
Control group: Head trauma patients who had mechanical ventilation for more than 48 hours and had criteria for entering the study and were routinely weaning from the mechanical ventilation device
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee hospital in Qazvin
Full name of responsible person
Sareh Mohammadi
Street address
Qazvin University of Medical Sciences, No. 456,Gargani Street ,Padegan Street, Shahid Rajaee Hospital, Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
hosrajaee@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peimani
Street address
Shahid Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 5333360012898
Email
info@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
Master's degree nursing specialist
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Ave,Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
Email
s.mohammadi@qms.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sareh Mohammadi
Position
Master's degree nursing specialist
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Ave,Qazvin
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Fax
Email
s.mohammadi@qms.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available