Comparison of two methods open and closed endotracheal suctioning on clinical outcomes in preterm neonates in NICUs of Alzahra and Taleghani Teaching Hospitals, Tabriz, 2012
This study is a single blind clinical trial in order to compare clinical outcomes of two methods open and closed endotracheal suctioning. A population of preterm neonates with 27-34 weeks of gestational age born at Alzahra and Taleghani hospitals of Tabriz are to be studied; whom after their admission to NICU they are intubated with in maximum 24 hours and will be under mechanical ventilation at least for 48 hours. After verifying sample size, the neonates are elected by available simple sampling method and randomly divided between two study groups. First group will be suctioned by open and second suctioned by closed method. In both groups, suctioning as PRN and will be continued for atlleast48 hours. BP, HR, O2SAT in both groups should be recorded one minute before and one and five minutes after procedure, and registered in the special data forms designed by research team. However frequency of suctioning and side effects as pulmonary hemorrhage, IVH, pneumothorax, pneumonia and septicemia until extubation and as well as duration of hospitalization. Side effects should be confirmed by a specialist who is blind to suction kind. Finally the above mentioned results will be compared for both groups. Analysis of data is to be done by using SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204078315N3
Registration date:2012-05-13, 1391/02/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-13, 1391/02/24
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-14, 1391/02/25
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods open and closed endotracheal suctioning on clinical outcomes in preterm neonates in NICUs of Alzahra and Taleghani Teaching Hospitals, Tabriz, 2012
Public title
Effect of endotracheal suctioning on clinical outcomes in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Preterm neonates of 27-34 weeks of gestational age born at Alzahra and Taleghani hospitals whom are admitted at NICU. 2- After maximum 24 hours of their admission to NICU are intubated due to the respiratory distress. 3- Neonates receiving surfactant. 4- Preterm neonates who are ventilated for at least 48 hours. 5- Neonates without congenital anomalies or heart diseases. 6- Neonates without MAS. 7- PROM less than 18 hours and 8- Neonates with less than 3 times of intubation trial.
Exclusion criteria: 1- Neonates with proved immune deficiency. 2- Neonates who are referred to other centers before completion of data and 3- Neonates whose congenital heart disease and ... is verified later.
Age
To 10 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Tabriz Medical Sciences Ethic Committee
Street address
Golgasht St.Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
913
Health conditions studied
1
Description of health condition studied
Evaluation of suction effect
ICD-10 code
J70.9
ICD-10 code description
Respiratory conditions due to unspecified external agent
Primary outcomes
1
Description
Verification and comparison of physiological stability
Timepoint
Befor one minute and after one minute and after five minute
Method of measurement
By the use of Monitoring
2
Description
Number of suctioning needed
Timepoint
Duration of time from first suctioning till extubation
Method of measurement
Data record form
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Untill discharch from NICU
Method of measurement
Data record form
2
Description
Side effects of suctioning
Timepoint
From 24 after first suctioning till extubation
Method of measurement
By use of data record form
Intervention groups
1
Description
In closed group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms .
Category
Treatment - Other
2
Description
In open group tracheal sactioning will be continued for atlleast48 huors. BP,HR,O2SAT should be recorded one minute before and one and five minutes after procedure,How ever frequency of suctioning and side effects as polmunary hemorage, IVH, penomotorax, ponomonia and septisemy until extubation and as well as duration of hospitalization registered in the special data forms .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra teaching hospitals
Full name of responsible person
Rahele Janani
Street address
Str. Southern Artesh, Baghshmal
City
Tabriz
2
Recruitment center
Name of recruitment center
Talegani teaching hospitals
Full name of responsible person
Rahele Janani
Street address
Rahahan st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Azadi Street - Street Golgasht - Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
Full name of responsible person
rahele janani
Position
MS nursing Student
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
00984114796770
Phone
+98 41 1328 0465
Fax
Email
rahele_janani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Leila Valizadeh
Position
Professor assistant
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
valizadehl@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Raheleh Janani
Position
MS Nursing Student
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing and Midwifery,South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1328 0465
Fax
+98 41 1328 0465
Email
rahele_janani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)