Determining the impact of the implementation of the management protocol of inconsistency between the patient and the ventilator on the clinical outcomes of patients admitted to the ICU
Design
A clinical trial with a control group with parallel, one-sided blind, randomized groups on 60 patients was used for randomization using the random permutation block method, spss software
Settings and conduct
This study is a randomized clinical trial and is conducted in the Mega ICU1 department of Golestan Ahvaz Hospital. The sample size is 60 people who will be divided into two intervention and control groups by random number table. The study is one-sided blind
Participants/Inclusion and exclusion criteria
• Age range between 15 and 65 years
• Patients who are under mechanical ventilation with a ventilator.
• No more than 3 days have passed since the patient was admitted to the ICU.
• Informed consent from the legal guardian for the patient's participation in the study
• Apache 2 score between 30 and 50
Having a spontaneous breathing effort in addition to the forced breaths of the ventilator (the patient is on assisted-controlled or spontaneous modes)
Intervention groups
Patients are divided into two groups, an intervention group and a control group. In the intervention group, the protocol is executed for 60 seconds until the lack of synchronization between the patient and the device is resolved. This cycle continues. The control group received routine care
Main outcome variables
The duration of connection to the ventilator, asynchrony between the patient and the device, the rate of death of the patient, spontaneous extubation of the patient
General information
Reason for update
Acronym
PVA
IRCT registration information
IRCT registration number:IRCT20231001059572N1
Registration date:2023-12-08, 1402/09/17
Registration timing:prospective
Last update:2023-12-08, 1402/09/17
Update count:0
Registration date
2023-12-08, 1402/09/17
Registrant information
Name
Maryam Roozeahvazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 4852
Email address
roozehahvazi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-31, 1403/05/10
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing a management protocol of patient-ventilator asynchrony on the clinical outcomes of patients admitted to ICU
Public title
pva review
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Connecting to the ventilator
Do not be under ventilator for more than three days
Apache score between 30 and 50
Having the informed consent of the patient's guardian
Age range from 15 to 65 years
Having a spontaneous breathing effort in addition to the forced breathing of the ventilator
Exclusion criteria:
Receiving neuromuscular blocking drugs during the study
Creating conditions that cause the patient to be on the controlled modes of the ventilator for a long time (such as brain death)
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized clinical trial in two intervention and control groups. The sample size was determined based on the findings of previous studies with the help of the med calc statistical software with a power of 90% and an error of 10%, 60 cases (30 people in each group).
Due to the possibility of sample dropout, 10% will be added to the above sample size. First, the samples will be selected according to the available sampling method according to the entry criteria, and then using the replacement block randomization method in the two intervention groups. and control (33 people each) will be randomly assigned. In this way, 11 blocks of 6 will be selected and then one of the 6 combinations of two groups will be assigned in each block
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Golestan St., Jundishapur University of Medical Sciences, Ahvaz, Faculty of Nursing and Midwifery
City
ahvaz
Province
Khouzestan
Postal code
۶۱۵۴۸۷۸۴۲۵
Approval date
2023-12-07, 1402/09/16
Ethics committee reference number
1402.472
Health conditions studied
1
Description of health condition studied
Patients who need to be connected to a ventilator due to breathing problems or other problems
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The duration of dependence on the ventilator
Timepoint
The number of days dependent on the ventilator
Method of measurement
check list
Secondary outcomes
1
Description
Length of hospitalization in the special ward
Timepoint
The number of days of hospitalization in the special ward
Method of measurement
check list
Intervention groups
1
Description
In the intervention group, the researcher checked the mechanical ventilation status of the patients twice a day during the morning and evening shifts using the patient asynchrony management protocol and the ventilator device and, if necessary, took the necessary care and treatment based on the PVA management protocol and in coordination He will do for the patient with the ICU specialist doctor and the nurses in the ward. The control group will receive routine ward care. In the control group, the routine care of the patients is received by the relevant personnel, and the protocol was not taught to the nurse
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mohammad Adinae
Street address
Golestan - Farvardin St. - Golestan Educational and Medical Center
City
ahvaz
Province
Khouzestan
Postal code
۶۱۵۴۸۷۸۴۲۵
Phone
+98 61 3374 3009
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
mohamad adine
Street address
Jundishapur University of Medical Sciences, Ahvaz, Vice President of Research
City
ahvaz
Province
Khouzestan
Postal code
۶۱۵۴۸۷۸۴۲۵
Phone
+98 61 3374 3009
Email
mohadineh@gmail.com
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 rozeahvazy
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan, Isfahan Street, Isfahan Complex, Unit 7
City
ahvaz
Province
Khouzestan
Postal code
6136844368
Phone
+98 61 3375 4852
Email
maryamrozeahvazy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohamad adine
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Street, Jundishapur University of Medical Sciences, Ahvaz, Faculty of Nursing and Midwifery
City
ahvaz
Province
Khouzestan
Postal code
۶۱۵۴۸۷۸۴۲۵
Phone
+98 61 3374 3001
Email
mohadineh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Roozeahvazi
Position
Senior students
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan, Isfahan Street, between Bahman and Esfand, Isfahan Complex, Unit 7
City
Ahvaz
Province
Khouzestan
Postal code
6136844368
Phone
+98 61 3375 4852
Fax
Email
roozehahvazi.m@ajums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available