The purpose of this randomized clinical trial is to investigate the effect of positive pressure during extubation of oro-tracheal ventilated neonates in prevention of post extubation atelectasis. We include 53 neonates who are under oro-teracheal mechanical ventilation for at least 24 hours and are ready for extubation. The intervention under study is extubation the neonates with positive pressure by T-Piece Resuscitator connected to endotracheal tube. In control group neonates will extubate with negative pressure as a conventional method by suction catheter of endotracheal tube. Post extubation atelectasis in CXR of 4 and 24 hours after extubation is investigated as the primary outcome in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112092801N2
Registration date:2011-12-29, 1390/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-29, 1390/10/08
Registrant information
Name
Roya Farhadi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 3018
Email address
rfarhadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor research of Mazandaran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of positive pressure during removal of endo tracheal tube on prevention of post extubation atelectasis in ventilated neonates
Public title
Effect of positive pressure on prevention of post extubation atlectasis in neonates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all neonates under oro-teracheal mechanical ventilation at least for 24 hours and are ready to extubation. Exclusion criteria are: 1-neonates suffer from broncho- pulmonary dysplasia; 2-Congenital anomaly of head and neck and thoracic cavity; 3-Naso-teracheal intubation; 4-Symptomatic PDA in echocardiography; 5- Congenital neuromuscular disorders; 6-IVH grade 3, 4; 7-Asphixia.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
53
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University Of Medical Sciences
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street
City
Sari
Postal code
4817844718
Approval date
2011-11-09, 1390/08/18
Ethics committee reference number
90-113
Health conditions studied
1
Description of health condition studied
atelectasis
ICD-10 code
J98.1
ICD-10 code description
Pulmonary collapse
Primary outcomes
1
Description
atelectasis
Timepoint
4 annd 24 hours after extubation
Method of measurement
observation of chest X ray
Secondary outcomes
1
Description
extubation Failure
Timepoint
during 48 hours after extubation
Method of measurement
observation
2
Description
Apnea
Timepoint
during 72 hours after extubation
Method of measurement
observation and respiratory monitoring
3
Description
pneomothoraxs
Timepoint
during 72 hours after extubation
Method of measurement
Chest x ray
Intervention groups
1
Description
Intervention: Removal of endotheracheal tube with positive pressure by a T-Piece Resusciator connected to endotheracheal tube regulated
Category
Prevention
2
Description
Control: Removal of endotheracheal tube with negative pressure with suction of endotheracheal tube during Extubation (100 mmHg)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali Sina Hospital
Full name of responsible person
Roya Farhadi
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor research, Mazandaran University of Medical Sciences, Moallem street
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant Professor, Neonatologist
Other areas of specialty/work
Street address
BooAli Sina Hospital
City
Sari
Postal code
Phone
+98 15 1223 3011
Fax
Email
dr.royafarhadi@gmail.com , rfarhadi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Roya Farhadi
Position
Assistant professor, Neonatologist
Other areas of specialty/work
Street address
BooAli Sina Hospital
City
Sari
Postal code
Phone
+98 15 1223 3011
Fax
Email
dr.royafarhadi@gmail.com , rfarhadi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)