Protocol summary

Study aim
Knowledge of effectiveness of using BiPAP for successful weaning in children with underlying neurological problems admitted to the PICU of Motahari hospital can be helpful in patient management.
Design
Two arm parallel group randomised trial
Settings and conduct
As pilot,12 intubated patients, admitted to the PICU with underlying neurological disease will be included in each arm of the study. Randomization will be performed using Random Number Generation software. Inclusion criteria include intubation and underlying neurological disease, and exclusion criteria include having other associated underlying diseases. patients After meeting the conditions for weaning, such as consciousness and spontaneous breathing and the need for a low percentage of oxygen, weaning from the ventilator and immediately undergoing assisted breathing, Bilevel Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure(CPAP) and were monitored for respiratory status for the next 72 hours.They are evaluated for the need of reintubation, and if there is no need for reintubation within 72 hours of extubation, the separation considered successful. Also duration of hospitalization of patients in two groups, as well as the associated complications, are evaluated. The rate of successful weaning considered as primary outcome and the duration of hospitalization and complications as the secondary outcome.
Participants/Inclusion and exclusion criteria
Inclusion: Intubation and having underlying neurological disease. Exclusion: Having other underlying diseases such as heart disease.
Intervention groups
Patients aged 1 month to 18 years who have underlying neurological disease and admitted to the PICU and are intubated. Of these, randomly 12 individuals will be placed under BiPAP after extubation and 12 randomly selected individuals will be placed under NCPAP. BiPAP , CPAP
Main outcome variables
Successful weaning

General information

Reason for update
Acronym
(CPAP)Bilevel Positive Airway Pressure(BiPAP), Continuous Positive Airway Pressur
IRCT registration information
IRCT registration number: IRCT20250330065181N1
Registration date: 2025-06-17, 1404/03/27
Registration timing: registered_while_recruiting

Last update: 2025-06-17, 1404/03/27
Update count: 0
Registration date
2025-06-17, 1404/03/27
Registrant information
Name
Tohid Ebadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3657 2318
Email address
tohid2ebadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of using BiPAP and CPAP for successful weaning from the ventilator in children with underlying neurological problems admitted to the PICU
Public title
Comparing the effectiveness of using BiPAP and CPAP for successful weaning from the ventilator in children with underlying neurological problems admitted to the PICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with underlying neurological disease. Children who are intubated.
Exclusion criteria:
Children with other underlying diseases such as heart disease.
Age
From 1 month old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using Random Number Generation software. Random generator is a simple software for generating random numbers between two specified numbers, where the discrete numbers are from 1 to 24 and each patient is identified by a number. First, the software randomly selects 12 numbers from 1 to 24, which are assigned to 12 intubated patients with underlying neurological problems and will be placed on BiPAP. The remaining 12 numbers from 1 to 24 will be assigned to other intubated patients with neurological problems and will be placed on CPAP. Now, patients are assigned numbers one to 24 in order of admission and are put on BiPAP or CPAP. For example, initially according to the software, we have 12 numbers that are supposed to be put on BiPAP, for example, numbers 3,4,7,11,13,14,... Now, the first patient with the entry criteria will be number one and will be put on CPAP. The next patient is assigned number 2 and is put on CPAP. The next patient is assigned number 3 and is put on BiPAP, and so on, up to 24 patients.
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
Urmia University of Medical Sciences Ethics Committee
Street address
No 11, Borujerdi Street
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Approval date
2024-12-21, 1403/10/01
Ethics committee reference number
IR.UMSU.REC.1403.282

Health conditions studied

1

Description of health condition studied
Neurological diseases
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
Successful extubation
Timepoint
72 hours after extubation
Method of measurement
Information collection form

Secondary outcomes

1

Description
Complications of intubation
Timepoint
72 hours after extubation
Method of measurement
Information collection form

Intervention groups

1

Description
Control group: 12 intubated patients with underlying neurological disease, who were randomly selected, were weaned from the ventilator after meeting the conditions and immediately underwent Continuous Positive Airway Pressure(CPAP), respiratory assistance, using an anatomical face mask and were monitored for 72 hours for the need for re-intubation.
Category
Treatment - Other

2

Description
Intervention group: 12 Intubated patients with underlying neurological disease, who were randomly selected, were weaned from the ventilator after meeting the conditions and immediately underwent Bilevel Positive Airway Pressure(BiPAP), respiratory assistance, using an anatomical face mask and were monitored for 72 hours for the need for re-intubation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari hospital, Urmia
Full name of responsible person
Tohid Ebadi
Street address
No11, Borujerdi street
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Phone
+98 44 3657 2318
Email
Tohid2ebadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Golizade
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Phone
+98 44 3657 2318
Email
Tohid2ebadi@gmail.com
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Ebadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Borujerdi
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Phone
+98 44 3657 2318
Email
Tohid2ebadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Ebadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Borujerdi
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Phone
+98 44 3657 2318
Email
Tohid2ebadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Ebadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Borujerdi
City
Urmia
Province
West Azarbaijan
Postal code
5713147454
Phone
+98 44 3657 2318
Email
Tohid2ebadi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Successful extubation rate
When the data will become available and for how long
1 Mon
To whom data/document is available
Mohammad Salavatizade, Mohammad Valizade, Babak Hasanlooyi, Tohid Ebadi
Under which criteria data/document could be used
After statistical analysis
From where data/document is obtainable
Tohid Ebadi
What processes are involved for a request to access data/document
Email
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