Comparison of Continuous positive airway pressure ventilator with T-Piece and humidifier on outcome of weaning of children admitted to intensive care unit ward
(1) Objectives: Our aim in this study is to compare effect of Continuous positive airway pressure ventilator and T-piece and humidifier in the outcome of weaning patients from mechanical ventilation. (2) Design: Fifty patients from both genders admitted for any reason to pediatric intensive care unit ward, Tabriz children Hospital, Tabriz will be included in the study. In a double blinded study patients will be randomized into two groups of Continuous positive airway pressure ventilator and T-piece and humidifier and will be included in the clinical trial after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: Fifty patients from both genders admitted for any reason to pediatric intensive care unit ward, Tabriz children Hospital, Tabriz will be included in the study and will be divided into two groups of 25. Inclusion criteria are age between 1 month and 14 years old; admission to pediatric intensive care unit ward; being intubated. Exclusion criteria are patient intolerance in Continuous positive airway pressure stage; having difficulty to wean the patient as the result of neurological or muscular lesion. (4) Intervention: Fifty patients will be divided into two groups of Continuous positive airway pressure ventilator and T-piece and humidifier. If there is a spontaneous breathing with receiving a FiO2 lower than 40 percent and PaO2 is higher than 60, patient will be candidate for weaning. (5) Main outcome measures: Days of mechanical ventilation, need to reintubate the patient, days of hospital admission, days of intensive care unit ward admission and in-hospital mortality which will be evaluated daily for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013043013189N1
Registration date:2013-06-20, 1392/03/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-20, 1392/03/30
Registrant information
Name
Shalaleh Ganji
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 5518
Email address
ganji575@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Continuous positive airway pressure ventilator with T-Piece and humidifier on outcome of weaning of children admitted to intensive care unit ward
Public title
Comparison of using two kinds of devices in respiration of hospitalized children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 1 month and 14 years old; admission to pediatric intensive care unit ward; being intubated.
Exclusion criteria: patient's intolerance in Continuous positive airway pressure ventilator stage; having difficulty to wean the patient as the result of neurological or muscular lesion.
Age
To 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For randomizing patients into two groups we used pocket method. We used a double blinded study to prevent research outcomes from being influenced by the placebo effect or observer bias.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
91169
Health conditions studied
1
Description of health condition studied
Acute respiratory failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
2
Description of health condition studied
Chronic respiratory failure
ICD-10 code
J96.1
ICD-10 code description
Chronic respiratory failure
3
Description of health condition studied
Respiratory failure
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified
Primary outcomes
1
Description
Days of mechanical ventilation
Timepoint
After intubation will be counted daily
Method of measurement
Questionnaire
2
Description
Days of hospitalization
Timepoint
After admission will be counted daily
Method of measurement
Questionnaire
3
Description
Days of intensive care unit admission
Timepoint
After intubation will be counted daily
Method of measurement
Questionnaire
Secondary outcomes
1
Description
In-hospital mortality
Timepoint
At the end of admission period
Method of measurement
Questionnaire
Intervention groups
1
Description
In continuous positive airway pressure ventilator group, patients will be ventilated with continuous positive airway pressure ventilator
Category
Treatment - Devices
2
Description
In T-Piece and humidifier group, patients will be ventilated with T-Piece and humidifier
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Shalaleh Ganji
Street address
Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr. Shalaleh Ganji
Position
Pediatric diseases resident
Other areas of specialty/work
Street address
Department of Pediatric diseases, Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1330 6709
Fax
Email
ganji575@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr. Nemat bilan
Position
Professor/ Specialty in children's lung diseases
Other areas of specialty/work
Street address
Department of Pediatric diseases, Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1330 6709
Fax
Email
bilan@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr. Shalaleh Ganji
Position
Pediatric diseases resident
Other areas of specialty/work
Street address
Department of Pediatric diseases, Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1330 6709
Fax
Email
ganji575@gmail.com; majid593@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)