| CTRI Number |
CTRI/2020/09/028175 [Registered on: 30/09/2020] Trial Registered Prospectively |
| Last Modified On: |
29/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Proportion of patients who are unable to get liberated from artificial breathing machine and their characteristics. |
|
Scientific Title of Study
|
Incidence and predictors of extubation failure in children undergoing mechanical ventilation: a prospective cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lolam Venkatesh |
| Designation |
DM SR |
| Affiliation |
JIPMER |
| Address |
604, Harvey 2 hostel, JIPMER
Puducherry
JIPMER, puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8727003332 |
| Fax |
|
| Email |
lolamvenkatesh502@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayanan P |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Dept of pediatrics, WCH block JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443458850 |
| Fax |
|
| Email |
narayanan.p@jipmer.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lolam Venkatesh |
| Designation |
DM SR |
| Affiliation |
JIPMER |
| Address |
Dept of Pediatrics
WCH Block
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8727003332 |
| Fax |
|
| Email |
lolamvenkatesh502@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER, pondicherry |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lolam Venkatesh |
JIPMER |
Ward 269, Dept of pediatrics, WCH block, JIPMER, Puducherry, 605006
Pondicherry
PONDICHERRY |
8727003332
lolamvenkatesh502@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
all children admitted in PICU on mechanical ventilation |
|
| ExclusionCriteria |
| Details |
1.Children who had accidental extubation.
2.Children who expire during their PICU stay
3.Children who have undergone tracheostomy after few days of intubation.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| extubation failure |
with in 48 hours of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify risk factors associated with extubation failure.
a. Clinical parameters: age, diagnosis, comorbidities
b. Ventilatory parameters: Oxygenation index, duration of mechanical ventilation
c. Result of Spontaneous breathing trial (SBT)
d. Serum levels of B Type Natriuretic peptide (BNP)
|
SBT done for 30 min to 2 hours |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
mechanical ventilation is a common treatment for critically ill children admitted to pediatric intensive care unit. extubation failure is associated with increased morbidity and mortality. extubation failure rate across world various studys is from 2.7-22%. several indices and biomarkers including BNP were studied for association with failed extubation. there are no indian studies in pediatric intensive care unit to validate risk factors to extubation failure. our research question is - what is the incidence of extubation failure in children undergoing mechanical ventilation. and what are the predictors of extubation failure in children undergoing mechanical ventilation. all children undergoing mechanical ventilation who are meeting inclusion criteria will be included instudy after obtaining appropriate informed consent. details of demography, clinical, and mechanical ventilation paramteres wil be recorded. decision to extubation will be taken by treating team of PICI. before extubation all children will undergo Spontaneous breath trial as per PICU protocol . 1st BNP sample will be taken when decision extubation (and sedation stopped), and 2nd BNP at end of SBT. children who tolerated and passed SBT will be extubated. extubation failure will be defined as requirement of reintubation due to any reason with in 48 hours of extubation. data will be analysed as per appropriate statistical test, . |