Comparision of two methods according to clinical judgment and protocol in extubation on mechanical ventilation duration and extubation failure in children
Comparison of two extubation methods on mechanical ventilation duration and extubation failure on children admitting in PICU
Design
Randomized clinical trial with parallel control group
Settings and conduct
This study is conducted in Isfahan Imam Hossein Children's Hospital,PICU. After determining the inclusion and exclusion criteria, patients are divided into two groups. In the intervention group, protocol is performed, and the tracheal tube is removed if it is successful. Extubation is performed in the control group based on the physician's clinical decision. The patients undergo non-invasive mechanical ventilation or reintubation if the failure criteria being met within two days of extubation.
Participants/Inclusion and exclusion criteria
All infants and children admitted and intubated in PICU and who have been receiving MV for >12 hrs,are included.
The exclusion criteria are as follows: intubation due to upper airway obstruction, chronic MV use, cyanotic congenital heart disease, primary pulmonary hypertension,neuromuscular disease and tracheostomy.
Intervention groups
In study group, patients have to meet the readiness criteria undergo to spontaneous breathing test.
Ventilator setting in 0.5 hour SBT is Spont/PSV. If there are stable vital signs,not hypoventilation and unconsciousness; and acceptable ABG during the test, patients are extubated and get 100% oxygen.
Extubation is done in control group according to physician clinical judgment.
Main outcome variables
1- extubation failure
2- mechanical ventilation duration in successful extubation
3- length of PICU stay
4- length of hospital stay
5- mortality in PICU
6- reintubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190219042766N1
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Atefeh Sadeghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3630 8104
Email address
a.sadeghizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-27, 1398/04/06
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of two methods according to clinical judgment and protocol in extubation on mechanical ventilation duration and extubation failure in children
Public title
Extubation method on extubation failure and mechanical ventilation duration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infants and children ،aged between 1 month to 14 years، admitted in PICU
Patients have been receiving MV above 12 hours
Exclusion criteria:
Intubation due to upper airway obstruction (UAO)
neuromuscular disease
tracheostomy
chronic MV use
cyanotic congenital heart disease
primary pulmonary hypertension.
Age
From 1 month old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with two numbers in each block
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱- -۸۱۷۴۶
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.MUI.MED.REC.1398.072
Health conditions studied
1
Description of health condition studied
Extubation method
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mechanical ventilation duration
Timepoint
9 months
Method of measurement
Hospital admission file
2
Description
extubation failure
Timepoint
9 months
Method of measurement
Hospital admission file
Secondary outcomes
1
Description
Length of hospital stay
Timepoint
9 months
Method of measurement
Hospital admission file
2
Description
Length of PICU stay
Timepoint
9 months
Method of measurement
Hospital admission file
3
Description
Mortality in PICU
Timepoint
9 months
Method of measurement
Hospital admission file
Intervention groups
1
Description
In intervention group,the readiness criteria included the following are evaluated: recovery or eliminating of their underlying causes for respiratory failure and intubation, T<38.5 ºC, HB> 8, ability to swallow secretions, having gag or cough reflexes during suctioning the secretions, having an acceptable level of consciousness, i.e. GCS score≥8 after discontinuing sedations and analgesics, correction of electrolytes, absence of new findings in the chest X-ray, no needs for increasing the settings of the ventilator over the previous 24 hours, the total discontinuation of sedations and analgesics in at least the previous six hours, no needs for vasoactive agents, an acceptable arterial-blood gas and air exchange with StO2>94% despite FiO2<40, PIP<20 and PEEP<5.If they meet all criteria, the ventilator settings are set as follows: Mode: Spont/PSV, PEEP≤5, FiO2≤40, PS according to ET size (3-3.5:10, 4-4.5:8, ≥5:6). The SBT failure is confirmed in case at least two of the following conditions are observed during the intervention: respiratory rate being outside the normal range by age, i.e. tachypnea or bradypnea, respiratory distress, VTe<5 ml/kg, SatO2<90%, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease in the final arterial-blood gas test. If the test failed, the parameters and mode of the ventilator are set as before the test, and if the clinical criteria are met as described, the test is repeated 24 hours later.Endotracheal tube is immediately extracted if the test is successful, and the patient is provided with a non-rebreathing face mask with a 10-15 l/min flow, and undergo100% oxygen therapy. Arterial-blood gas test is performed two hours after extubation. Extubation failure is confirmed in case at least two of the following symptoms emerged within two days of extubation: respiratory distress, hypoxia with SatO2<90%, respiratory rate outside the normal range by age, i.e. tachypnea or bradypnea , apnea>20 seconds, hypotension based on PALS guidelines or an over 20% increase in blood pressure, impaired consciousness associated with hypoventilation, heart rate outside the normal range by age, i.e. tachycardia and bradycardia, Pco2>55 mmHg or an increase in Pco2 by at least 10mmHg in patients with chronic pulmonary disease accompanied by PH<7.3 and symptoms of upper airway obstruction. In case of the absence of contraindications for NIMV, Bi-level positive airway pressure (BiPAP) is applied with minimum settings as EPAP:5 and IPAP:8-10, and tittered up to EPAP:8-10 and IPAP:5-22 and until clinical and laboratory symptoms of respiratory failure disappear. The patient is reintubated if respiratory failure symptoms persist after two hours of monitoring
Category
Treatment - Other
2
Description
In control group ,The attendant of pediatric or anesthesiology by ICU fellowship decides on ventilator settings and respiratory support reduction and extubation according to the results of arterial-blood gas tests performed at least once a day and based on the patient's clinical conditions, including eliminating the causes of intubation, appropriate ventilation and oxygenation and stable vital signs.The post-extubation oxygen supply method, the criteria of extubation failure and NIMV and reintubation protocols are as same as the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Imam Hussein Hospital
Full name of responsible person
Dr. Atefeh Sadeghizadeh
Street address
Isfahan,10 kilometer Imam Khomeini
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
A.sadeghizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Majid Keyvanfar
Street address
Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱ -۸۱۷۴۶
Phone
+98 31 3792 8134
Email
vcr-office@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
Dr Atefeh Sadeghizadeh
Position
PICU fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kilometer 10 Imam Khomeini Avenue- Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
a.sadeghizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr atefeh Sadeghizadeh
Position
PICU fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kilometer 10 Imam khomeini Avenue,Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
a.sadeghizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Atefeh Sadeghizadeh
Position
PICU fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Kilometer 10 Imam Khomeini Avenue,Imam Hussein Hospital
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
a.saghizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD