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Clinical Trials/CTRI/2024/09/073455
CTRI/2024/09/073455
Recruiting
Not Applicable

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

All India Institute of Medical Sciences Rishikesh1 site in 1 country52 target enrollmentStarted: September 16, 2024Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
52
Locations
1
Primary Endpoint
Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilation
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

**Research question:**In neonates failing conventional mechanical ventilation and requiring high-frequency oscillatory ventilation as a rescue mode (P), does the addition of volume guarantee with HFOV (I) compared to HFOV alone (C) reduce the incidences of hypo or hypercarbia (O)?

**Research hypothesis:**In neonates failing CMV and requiring HFOV as a rescue mode, the addition of VG with HFOV will reduce the incidences of hypo or hypercarbia.

**Aim of the study:**To determine the efficacy of HFOV with VG in neonates failing CMV and requiring HFOV as a rescue mode.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
0.00 Day(s) to 3.00 Month(s) (—)
Sex
All

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
  • •Peak positive pressure more than 26 cm H2O
  • •Mean airway pressure more than 12 cm H2O
  • •Diffuse atelectasis in chest x-ray requiring lung recruitment
  • •Refractory respiratory acidosis defined as pCO2 more than 60 mmHg and or pH less than 7.20
  • •Air leak syndrome in conventional mechanical ventilation.

Exclusion Criteria

  • •Major congenital malformations.

Outcomes

Primary Outcomes

Incidence of hypo or hypercarbia at 1 hour after starting high frequency oscillatory ventilation

Time Frame: At 1 hour

Secondary Outcomes

  • 1. Incidence of hypo or hypercarbia at 6, and 24 hours after starting HFOV(2. Any incidence of hypo or hypercarbia during HFOV)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sriparna Basu

All India Institute of Medical Sciences, Rishikesh

Study Sites (1)

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