Post intubation airway secretion suction effects on respiratory parameter in children
Design
Controlled randomized clinical trial, with parallel groups, double-blinded, randomized
Settings and conduct
This study will carried out as a clinical trial and among the referring children to Tabriz Children’s hospital (June 2018 to March 2019) who are surgery candidates and have pulmonary crackles, 100 cases will chosen randomly and will divide into two groups of case and control.
Each patient will be auscultated by a pediatric anesthesia specialist. If diagnosed with abnormal auscultation , patient enters the study , regardless of the intensity of abnormality and will be compared with him/her self before and after suction. The patients, the person responsible of recording vital signs and analyzer of data are not informed about whether the airways have been suctioned or not.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Patients who are between 1 month to 6 years old and in need of intubation for surgery witch have coarse crackle in auscultation caused by secretion
2- urgent Patients with common cold
exclusion criteria
patients with persistent pulmonary hypertension (PPH), fever, and airway malformation
Intervention groups
patients will be divided in two groups for study:
patients who had tracheal suction before surgery
patients without tracheal suction before surgery
in first group post intubation suction will be performed open and deeply,2 or 3 times till all secretions are eliminated and abnormal sounds are gone.Patients will be ventilated after every suction.in second group anesthesia will continue without pulmonary secretions suction.
Main outcome variables
Respiratory rate; Heart rate; SPO2; Expiratory CO2; Blood pressure and pressure of the airway before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100527004041N14
Registration date:2018-06-26, 1397/04/05
Registration timing:retrospective
Last update:2018-06-26, 1397/04/05
Update count:0
Registration date
2018-06-26, 1397/04/05
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
deputy of research and technology
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
Effect of post intubation endotracheal suction before surgery on respiratory parameters in children with airway secretion
Public title
Effect of post intubation endotracheal suction on respiratory parameters in children with airway secretion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are between 1 month to 6 years old
Patients need to intubate for surgery
Patients have coarse crackle in auscultation caused by secretion.
Urgent Patients with common cold
Exclusion criteria:
patients with persistent pulmonary hypertension(PPH)
fever
children with airway malformation
Age
From 1 month old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
the surgery candidate children in "The children medical research and training hospital, Tabriz" will randomly be chosen using random number table and random permuted blocks divided in two 50 members groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each patient will be auscultated by a pediatric anesthesia specialist. If diagnosed with abnormal auscultation , patient enters the study , regardless of the intensity of abnormality and will be compared with him/her self before and after suction.The data will be gathered by a pediatric anesthesia specialist with help of experienced nurses. Patients, the person who responsible of recording vital signs and analyzer of data are not informed about whether the airways have been suctioned or not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
university /regional research ethics committee Tabriz university medical of sciences
Street address
Tabriz Unversity of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.TBZMED.REC.1397.204
Health conditions studied
1
Description of health condition studied
Patients with abnormal pulmonary auscultation
ICD-10 code
J20
ICD-10 code description
Acute bronchitis
Primary outcomes
1
Description
short time side effects
Timepoint
discharge from recovery
Method of measurement
observational
2
Description
Respiratory rate
Timepoint
Before surgery-during recovery
Method of measurement
Vital signs monitoring device
3
Description
Heart rate
Timepoint
Before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery.
Method of measurement
Vital signs monitoring device
4
Description
SPO2( Blood Oxygen Saturation)
Timepoint
Before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery
Method of measurement
pulse oximeter
5
Description
Expiratory CO2
Timepoint
every 15 minutes after intubation
Method of measurement
Vital signs monitoring device
6
Description
Blood pressure
Timepoint
before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery.
Method of measurement
Vital signs monitoring device
7
Description
pressure of the airway
Timepoint
every 15 minutes after intubation
Method of measurement
Anesthesia manometer
Secondary outcomes
empty
Intervention groups
1
Description
Cases:Patients who had tracheal suction before surgery patients without tracheal suction before surgery in first group post intubation suction will be performed open and deeply,2 or 3 times till all secretions are eliminated and abnormal sounds are gone.Patients will be ventilated after every suction.
Category
Prevention
2
Description
Control group:in control group anesthesia will continue without pulmonary secretions suction
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz children hospital
Full name of responsible person
Mahin Seyed Hejazi
Street address
Tabriz children hospital, Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
seidhejazie@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hasan Soleymanpour
Street address
Tabriz university of medical sciences, Golgasht st
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyed Hejazi
Position
Head of pediatric anesthesia department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz children hospital , Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2257
Fax
Email
seidhejazie@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Seyed Hejazi
Position
Head of pediatric anesthesia ward/pediatric anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz children hospital , Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2257
Fax
Email
seidhejazie@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
Mahin Seyed Hejazi
Position
Head of pediatric anesthesia ward/pediatric anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz children hospital, Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2257
Fax
Email
seidhejazie@yahoo.com
Web page address
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
we are going to publish all in a paper
When the data will become available and for how long
in the end of study
To whom data/document is available
every one who read the paper
Under which criteria data/document could be used
If the data is needed to be used for further analysis, only the study designer has access to the codes and patients information. If the data is going to be used in another study, a proposal (in which the goals of study are established) should be registered and ethics code must be received.
From where data/document is obtainable
from the paper
What processes are involved for a request to access data/document