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Vibrating machine breathing support with additional gas in small babies.

High-frequency Oscillatory Ventilation with or without Volume Guarantee in Neonates: A Randomized Controlled Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073455
Enrollment
52
Registered
2024-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: High-frequency oscillatory ventilation with volume guarantee: Once recruited, neonates will be started on high-frequency oscillatory ventilation along with volume guarantee. The initial

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor
Sriparna Basu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates who fail conventional mechanical ventilation and require high-frequency oscillatory ventilation as a rescue mode. CMV failure will be defined as the presence of any of the following 1. Peak positive pressure more than 26 cm H2O 2. Mean airway pressure more than 12 cm H2O 3. Diffuse atelectasis in chest x-ray requiring lung recruitment 4. Refractory respiratory acidosis defined as pCO2 more than 60 mmHg and or pH less than 7.20 5. Air leak syndrome in conventional mechanical ventilation

Exclusion criteria

Exclusion criteria: Major congenital malformations

Design outcomes

Primary

MeasureTime frame
Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilationTimepoint: At 1 hour

Secondary

MeasureTime frame
1. Incidence of hypo or hypercarbia at 6, and 24 hours after starting HFOV 2. Any incidence of hypo or hypercarbia during HFOV 3. Total number of episodes of hypo or hypercarbia during HFOV 4. Measured high frequency tidal volume at 1, 6, 12, 24 and 48 hours as applicable 5. Cranial USG and cerebral blood flow in the anterior cerebral artery at baseline and one hour of HFOV 6. Regional cerebral oxygenation at baseline and one hour of HFOV 7. Duration of invasive mechanical ventilation 8. Duration of respiratory support in any form 9. Incidences of morbidities during hospital stay 10. Mortality 11. Duration of hospital stay Timepoint: During hospital stay

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

rahulkarthik281@gmail.com9121490270

Outcome results

None listed

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