Determining of the effect of nursing interventions based on Bern's tool on the success rate of Winging in the intensive care unit
Design
This research is a clinical trial with a sample size of 70 people. The method of assigning intervention to patients was randomized and random blocked blocks with block size 4 (using the table for random permutations). The randomization list is provided by a statistic specialist. The intervention used in this study is based on a randomized list by a person outside the study who is not aware of the research objectives and will be handled according to the corresponding codes within the sealed envelopes. In this way, the samples will be divided into two groups of intervention and control.
Settings and conduct
ICU Department of Ahvaz Golestan Hospital
Participants/Inclusion and exclusion criteria
Age of 18-65
Failure to develop Neuromuscular diseases
Do not receive Neuromuscular blockers
Exclusion Criteria: Brain death patients
Intervention groups
The intervention group consists of all patients aged 18-65 years old admitted to the intensive care unit and connected to a mechanical ventilation device, which will be weaning from the machine according to the criteria of the Bern list.weaning of the control group is performed according to the routine procedure.
Main outcome variables
Successful and unsuccessful weaning and Burn number
Duration of mechanical ventilation
The number of re-intubation
The index RSBI
Length of stay in ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041632N1
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Maryam Sepahyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 0804
Email address
sepahyar.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Nursing Interventions based on Bern's tool on the success rate of Weaning
Public title
The effect of Nursing Interventions based on Bern's tool on the success rate of Weaning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-65 Years
Failure to develop Neuromuscular diseases
Do not receive Neuromuscular blockers
Exclusion criteria:
Brain death Patients
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to patients was randomized and random blocked blocks with block size 4 (using the table for random permutations). A randomized list is provided by a statistician. The interrogation used in this study is based on a randomized list by a person outside the study who is not aware of the research objectives and will be conducted according to the different codes in the sealed envelopes.
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
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 104, Rezvan2 Ave, Payam Town
City
Ahvaz
Province
Khouzestan
Postal code
6138815339
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.AJUMS.REC.1397.599
Health conditions studied
1
Description of health condition studied
Traumatic patients connected to a mechanical ventilation device
ICD-10 code
S06.3
ICD-10 code description
Focal traumatic brain injury
2
Description of health condition studied
Traumatic patients connected to a mechanical ventilation device
ICD-10 code
S06.4
ICD-10 code description
Epidural hemorrhage
3
Description of health condition studied
Traumatic patients connected to a mechanical ventilation device
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural hemorrhage
4
Description of health condition studied
Traumatic patients connected to a mechanical ventilation device
ICD-10 code
S06.6
ICD-10 code description
Traumatic subarachnoid hemorrhage
Primary outcomes
1
Description
Successful and unsuccessful weaning
Timepoint
From weaning to 48 hours after it
Method of measurement
Registration in vital-laboratory variables questionnaire
Secondary outcomes
1
Description
Duration of mechanical ventilation connection
Timepoint
The number of days a patient connected to a ventilator
Method of measurement
Record in vital-laboratory questionnaire
2
Description
Length of admission to the intensive care unit
Timepoint
From the time of admission to the intensive care unit until the discharge from this department
Method of measurement
Demographic information questionnaire
3
Description
The number of re-intubation
Timepoint
From the beginning of the patient's connection to the ventilator until the patient's discharge from the department
Method of measurement
Vital Laboratory Information Questionnaire
4
Description
The RSBI index is the day before and after the weaning
Timepoint
The day before weaning and at the time of weaning
Method of measurement
Vital Laboratory Information Questionnaire
Intervention groups
1
Description
Nurses will plan and conduct nursing care for patients undergoing mechanical ventilation in the intervention group, according to Bern's checklist criteria.The researcher will evaluate the patients on a daily basis according to the checklist, and will complete the checklist for the intervention group, and will assess the readiness of the patient's weaning.If the optimal score (17 and above) is obtained, the process of weaning begins.In the absence of a desirable score, nursing interventions will focus more on the main problem that is identified in Bern during the day.
Category
Treatment - Other
2
Description
Control group: In the control group according to routine medical and weaning of patients with the use of certain criteria and will be done experimentally. The routine weaning method is such that the patient is alert, has a good cough and swallowing reflex, has no respiratory ventilation, and respiratory rate is not more than 35.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Shahram Baraz
Street address
Golestan, Farvardin Ave.,Golestan hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
+98 61 3374 3030
Email
golestanhospital@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Street address
Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 0250
Fax
Email
info@ajums.ac.ir
Web page address
ttpp://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Sepahyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.104, Rezvan2 Ave, Payam Town
City
Ahvaz
Province
Khouzestan
Postal code
6138815339
Phone
+98 61 3443 0804
Fax
Email
sepahyar.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Sepahyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.104, Rezvan2 Ave, Payam Town
City
Ahvaz
Province
Khouzestan
Postal code
6138815339
Phone
+98 61 3443 0804
Fax
Email
sepahyar.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Sepahyar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.104, Rezvan2 Ave, Payam Town
City
Ahvaz
Province
Khouzestan
Postal code
6138815339
Phone
+98 61 3443 0804
Fax
Email
sepahyar.m@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on age, sex, history of underlying illness, history of smoking and drug use, and duration of admission
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
Researchers of academic and academic institutions
Under which criteria data/document could be used
Use results
From where data/document is obtainable
maryamsepahyar@yahoo.com
0098 61 9166003501
What processes are involved for a request to access data/document