Investigating the use of recruitment with PEEP 8 in comparison to PEEP 3 before removing the tracheal tube in the success rate of extubation of hospitalized patients in the intensive care unit
Comparing the use of recruitment with PEEP 8 and the use of low PEEP before removing the tracheal tube in the success rate of extubation of patients hospitalized in ICU
Design
Based on standard wining criteria, 136 winnable patients will be randomly selected and divided into two groups. All patients will be on SBT for 1 hour with PS 3 and PEEP 3 and then will be divided into two groups using a simple randomization table: 1) A group that has the ability to be extubated, and will be extubated normally 2) One group will be recruited for half an hour with PEEP 8 and then extubated.
Settings and conduct
Intubated patients admitted to the intensive care unit of Imam Khomeini and Sinai hospitals who meet the criteria for extubation
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18 years and older, who were intubated for 3 to 7 days and who meet the standard weaning criteria and can be weaned
Exclusion criteria:
Patients with neuropathy diseases such as Guillain-barre and myasthenia gravis.
Intervention groups
In the intervention group, patients will be recruited for half an hour with PEEP 8 and then extubated. In the control group, patients will be extubated as usual
Main outcome variables
Comparing the use of recruitment with PEEP 8 and the use of low PEEP before removing the tracheal tube in the success rate of extubation of patients hospitalized in ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231112060026N1
Registration date:2024-05-09, 1403/02/20
Registration timing:prospective
Last update:2024-05-09, 1403/02/20
Update count:0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Mohammad Maroofian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 3446
Email address
mohammad.maroofian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the use of recruitment with PEEP 8 in comparison to PEEP 3 before removing the tracheal tube in the success rate of extubation of hospitalized patients in the intensive care unit
Public title
Investigating the use of recruitment with PEEP 8 in comparison to PEEP 3 before removing the tracheal tube in the success rate of extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intubated patients admitted to the ICU
Duration of intubation between 3 and 7 days
The patient will complete the winning criteria
Exclusion criteria:
Suffering from neuropathy diseases such as Guillain Barre and Myasthenia gravis .
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in block form and through the website www.sealedenvelop.com and patients will be randomly assigned to one of two groups.
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 Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.TUM.SINAHOSPITAL.REC.1402.012
Health conditions studied
1
Description of health condition studied
Extubation of patients under mechanical ventilation
ICD-10 code
Z99.11
ICD-10 code description
Dependence on respirator [ventilator] status
Primary outcomes
1
Description
The success rate of extubation of patients hospitalized in ICU
Timepoint
After being extubated
Method of measurement
Tolerance of extubation
Secondary outcomes
1
Description
Need to re-intubation
Timepoint
ِDialy until Discharge from ICU
Method of measurement
Clinical assessment
2
Description
Length of ICU stay
Timepoint
ِDialy until Discharge from ICU
Method of measurement
Patient records
Intervention groups
1
Description
Control group: A group that has the ability to be excluded will be excluded normally
Category
N/A
2
Description
Intervention group: will be recruited for half an hour with PEEP 8 and then extubated
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammad Taghi Beig Mohammadi
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mbage46@gmail.com
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex ICUs
Full name of responsible person
Dr. Mohammad Taghi Beigmohammadi
Street address
Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
ایمیلImamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Beig Mohammadi
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mbage46@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Beig Mohammadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 1619 0000
Email
mbage46@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Beig Mohammadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital Complex, Dr. Gharib Ave., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 1619 0000
Email
mbage46@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Beigmohammadi
Position
Associate Professor, Anesthesiology and Intensive Care, MPH, FCCM, Head of ICUs of Imam Khomeini Hos
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Qods st., Keshavarz Blv, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2511
Fax
+98 21 6693 5226
Email
beigmohammadi@tums.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
All data can be shared after de-identification of subjects and termination of the study.
When the data will become available and for how long
Access starts one year after the end of the study and publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
They will be allowed to use the documents to carry out research projects without changing the data analysis
From where data/document is obtainable
Imam Khomeini Hospital Complex, Dr. Gharib Ave, Keshavarz Blvd., Tehran. Postal code: 1419733141 Dr. Mohammad Taghi Beig Mohammadi Contact number :0098911759016 Email address: mbage46@gmail.com
What processes are involved for a request to access data/document
Face-to-face communication, phone calls, and email addresses are available and will be answered as soon as possible if eligible.