A comparative study on the effects of open and closed endotracheal suction systems on arterial blood gas parameters of children in pediatric intensive care unit
compare the effects of open and closed endotracheal suction systems on arterial blood gas (ABG) parameters of children admitted to ICUs
Design
This double-blind randomized clinical trial will compare the effects of the open suction system and closed suction system on ABG parameters in children admitted to the PICU
Settings and conduct
The study is done at Imam Hossein Hospital in Isfahan.The way of blindness is that the patient and the researcher do not know the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: stable hemodynamic conditions (blood pressure 72-102/104-120 mmHg, heart rate 75-100 bpm), ejection fraction (EF) > 50%, sufficient tissue perfusion (capillary refill < 2 s and normal urine output, i.e. 1.0 cc/kg), a body temperature of 35.5-38.5 ℃, normal hematocrit (36%-50%), normal hemoglobin (12-17 g/dl), normal PaO2 (80-100 mmHg), normal SO2 (95%-100%), normal PaCO2 (35-45 mmHg), normal HCO3 (22-28 mmHg), and normal pH (7.35- 7.45). Patients with obstructive pulmonary disease were not recruited. The participants were excluded if they were extubated or discharged against medical advice (with parental consent), or if they died before the end of the study.
Intervention groups
The selected children were randomly (alternately) allocated to two equal groups to receive either open or closed suction.
Main outcome variables
Arterial Blood Gas status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026866N6
Registration date:2018-07-04, 1397/04/13
Registration timing:registered_while_recruiting
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Amir Shafa
Name of organization / entity
Isfahan University of Medical Sciences, Imam hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2655
Email address
amir_shafa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-25, 1397/04/04
Expected recruitment end date
2018-09-25, 1397/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of open and closed endotracheal suction systems on arterial blood gas parameters of children in pediatric intensive care unit
Public title
A comparative study on the effects of open and closed endotracheal suction systems on arterial blood gas parameters of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stable hemodynamic conditions (blood pressure 72-102/104-120 mmHg, heart rate 75-100 bpm), ejection fraction (EF) > 50%, sufficient tissue perfusion (capillary refill < 2 s and normal urine output, i.e. 1.0 cc/kg), a body temperature of 35.5-38.5 ℃, normal hematocrit (36%-50%), normal hemoglobin (12-17 g/dl), normal PaO2 (80-100 mmHg), normal SO2 (95%-100%), normal PaCO2 (35-45 mmHg), normal HCO3 (22-28 mmHg), and normal pH (7.35- 7.45).
Exclusion criteria:
Lack of obstructive pulmonary disease
Age
From 3 months old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
patients and the researcher don not know the type of suction apply
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Imam Hossein Hospital, Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
ir.mui.rec.1396.3.95401
Health conditions studied
1
Description of health condition studied
This study aime to compare the effects of open and closed endotracheal suction systems on arterial blood gas (ABG) parameters of children admitted to ICUs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial blood gas status
Timepoint
1,5,15 minute after suction
Method of measurement
Arterial blood gas measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Suction is done with a closed system
Category
Treatment - Devices
2
Description
Control group: Suction is done with open system
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Shafa
Street address
Imam Hossein Hospital, Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezerjrib Ave.
City
Isfahan
Province
Isfehan
Postal code
8185665735
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam hossein Hospital, Imam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam hossein Hospital,Imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
81856 65843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Hossein Hospital, imam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
All data
When the data will become available and for how long
6 Month after print results
To whom data/document is available
All people
Under which criteria data/document could be used
No special condition
From where data/document is obtainable
Amir Shafa: shafa_amir@yahoo.com
What processes are involved for a request to access data/document