| CTRI Number |
CTRI/2025/09/094266 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Early versus Conventional Intubation in Children with Fluids Refractory Septic Shock] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Early Breathing Tube Placement in the Windpipe versus Conventional Timing of Breathing Tube Placement in Children with Severe Life-Threatening Infection and Poor Blood Flow to Human Body Organs. |
|
Scientific Title of Study
|
Comparing Outcome of Early Versus Conventional Intubation Practice in Children with Fluids Refractory Septic Shock-An Open Label Randomized Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himmat Ram Siyag |
| Designation |
Academic Senior Resident-Pediatric Emergency Medicine |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of Pediatrics, AIIMS, GE Road, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9929035999 |
| Fax |
|
| Email |
himmatsiyag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun Anand |
| Designation |
Additional Professor, Department of pediatrics, AIIMS Raipur |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of pediatrics, AIIMS, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9136044360 |
| Fax |
|
| Email |
varunanand@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Anand |
| Designation |
Additional Professor, Department of pediatrics, AIIMS Raipur |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of pediatrics, AIIMS, Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9136044360 |
| Fax |
|
| Email |
varunanand@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS), Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Himmat Ram Siyag |
| Address |
Department of Pediatrics, AIIMS Raipur, Tatibandh, Raipur chhattisgarh 492099 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Himmat Ram Siyag |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES(AIIMS), Raipur |
Department of pediatrics, AIIMS Raipur, Tatibandh, 492099, Raipur
Raipur
CHHATTISGARH |
9929035999
himmatsiyag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Intubation |
Children with Fluids refractory(Not Responding to 40ml/kg Fluids Bolus) Septic Shock will be started on Inotropes Supports and there will be Conventional intubation as per decision of treating physician eg. if child Sensorium worsen/Develops Hypoxia/worsening of Shock despite inotropes titration. |
| Intervention |
Early Intubation |
Early Intubation within 1 hour of Fluids Resuscitations in Children with Fluids Refractory(Not Responding to 40ml/kg fluids Bolus and Needs Inotropes supports) Septic Shock. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children with age 1 months -14 years age with Fluids Refractory Septic Shock will be enrolled after taking Consents from Parents/LAR. |
|
| ExclusionCriteria |
| Details |
1)Severe Anemia with CHF
2)Known cardiac Structural defect
3)known case of End Stage CKD
4)Children already Received Intubated from outside hospital
5)Children already received Fluids bolus from outside hospital
6)Children already received on Inotropes support from outside hospital
7)Post Cardiac Arrest patients |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Mortality in Early versus Conventional Intubation in Children with Fluids Refractory Septic Shock |
28 days Mortality Comparison |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Shock Resolution Time
2)Durations of Mechanical Ventilations
3)Durations of Inotropes supports
4)Duration of Hospital stay
5)Vasoactive Inotropes Scores(VIS)
6)Ventilation Free Days
7)Fluids Overloads Percentage
8)RRT Requirements
9)Other Complication of Intubation |
Fixing a specific time point for the secondary outcome is difficult, as the events mentioned in the secondary outcome may occur over a wide range of time. Enrolled patients will be follow up till Discharge(if Improved) from hospital or Till Mortality from PICU. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is An Open Label Randomized Controlled Trial With a Expected Sample Size Of 104 Patients Comparing Outcome of Early Intubation Versus Conventional Intubation in Children With Fluids Refractory Septic Shock Presenting in Pediatric Emergency Medicine After Taking Consent from parents and Patients Satisfying Inclusion and Exclusion Criteria. Patients Will be Randomized to Early Intubation and Conventional Intubation Arm. Stratified Block Randomization with Block Size 4 Will be used as Randomization method and Serially Numbered, Opaque, Sealed Envelopes will be used as Allocation Concealment. Primary Outcome- Comparision of 28 days Mortality and Seconadry outcomes includes Shock Resolution Time, Mechanical Ventilation Durations, Inotropes Supports Durations, Hospital Stay Durations, Vasoactive Inotropes Score(VIS), Ventilation Free Days, Percentage Fluids Overloads, Needs of Renal Replacement Therapy(RRT). |