The effect of open and closed endotracheal tube suctioning system on Cardio-respiratory parameters of infants undergoing mechanical ventilation in Isfahan's selected hospital on 2010
This study aimed to evaluate effect of open and closed suctioning
methods on respiratory parameters of infants undergoing mechanical ventilation.
Materials and Methods: In this crossover clinical trial, 44 infants were selected among those undergone mechanical
ventilation in NICU of Isfahan’s Al-Zahra Hospital using convenience sampling method.inclusion criteria were met: lack of neurological-muscle
diseases, congenital heart diseases and its resulted
impairment; and lack of active bleeding, fever, endotracheal
intubation and mechanical ventilation
exclusion criteria were met: extubation , blood transfusion, change in ventillator setting. The subjects were randomly
divided into two groups. In the first group, open suctioning was carried out and after three hours of cleaning, closed
suctioning was done. In the second group, closed suctioning was firstly done and following three hours of cleaning, open
suctioning was implemented. Respiratory rate (RR) and percentage of arterial blood oxygen saturation and respiratory rate was measured 3 minutes
before, during and immidiately after and 3 minutes after each type of suctioning.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040612908N1
Registration date:2013-04-28, 1392/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-28, 1392/02/08
Registrant information
Name
Narges Asgari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1364 1295
Email address
askari.nur@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Deputy of Isfahan University of Medical Sciences
Expected recruitment start date
2010-05-05, 1389/02/15
Expected recruitment end date
2011-01-22, 1389/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of open and closed endotracheal tube suctioning system on Cardio-respiratory parameters of infants undergoing mechanical ventilation in Isfahan's selected hospital on 2010
Public title
Effect of closed and open suctioning on Cardio-respiratory parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were met: lack of neurological-muscle
diseases, congenital heart diseases and its resulted
impairment; and lack of active bleeding, fever, endotracheal
intubation and mechanical ventilation
exclusion criteria : extubation , blood transfusion, change in ventillator setting
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jirib street, Azadi square, Isfahan
City
Isfahan
Postal code
Approval date
2009-12-22, 1388/10/01
Ethics committee reference number
12/11/5679/پ
Health conditions studied
1
Description of health condition studied
Cardio-respiratory parameters
ICD-10 code
p07.0, p0
ICD-10 code description
Extremely low birth weight dysmaturity - small(ness)- fetus or newborn for gestational age
Primary outcomes
1
Description
Blood pressure
Timepoint
2 minute before, during and 2 minute after suctioning
Method of measurement
Intensive care monitor
2
Description
Arterial blood oxygen saturation
Timepoint
3minute before, during,immidiately after and 3 minute after suctioning
Method of measurement
Pulse oximetry
3
Description
Pulse rate
Timepoint
3minute before, during,immidiately after and 3 minute after suctioning
Method of measurement
Pulse oximetry
4
Description
Respiratory rate
Timepoint
3minute before, during,immidiately after and 3 minute after suctioning
Method of measurement
Ventilator
Secondary outcomes
empty
Intervention groups
1
Description
In this study , the open suction is done on the samples. In this way, the neonate separated from the ventilator and suction catheter placed inside the tracheal tube and suction is done.
Category
Prevention
2
Description
Again the open suctioning in the same patient was performed after 3 hours closed suctioning is done. in this way the catheter placed in the ventilatory circuit and the possibility of suctioning performed without removing the patient from the ventilator
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan AL-Zahra Hospital
Full name of responsible person
Narges Asgari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Narges Asgari
Street address
Isfahan University of Medical Sciences, Hezar Jirib Street, Azadi Square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Scienses
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
Isfahan University of Medical Sciences
Full name of responsible person
Narges Asgari
Position
MSc. pediatric nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jirib Street, Azadi square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5770
Fax
Email
askari.nur@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Narges Asgari
Position
MSc.Pediatric Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, HezarJirib street, Azadi square, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5770
Fax
Email
askari.nur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Narges Asgari
Position
MSc. Pediatric Nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1668 5770
Fax
Email
askari.nur@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)