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.

Comparing Outcome of Early Versus Conventional Intubation Practice in Children with Fluids Refractory Septic Shock-An Open Label Randomized Control Trial. - NIL

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094266

Enrollment

104

Registered

2025-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: Children with age 1 months -14 years age with Fluids Refractory Septic Shock will be enrolled after taking Consents from Parents/LAR.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To Compare Mortality in Early versus Conventional Intubation in Children with Fluids Refractory Septic ShockTimepoint: 28 days Mortality Comparison	—

Secondary

Measure	Time frame
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 IntubationTimepoint: 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.	—

Measure

Time frame

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 IntubationTimepoint: 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.

—

Countries

India

Contacts

Public ContactDr Varun Anand

AIIMS, Raipur

varunanand@aiimsraipur.edu.in9136044360

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026