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NAVA in Infants With Acute Viral Bronchiolitis: A Feasibility Study

NCT05899894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-06-12

No results posted yet for this study

Summary

This exploratory intervention feasibility study aims to evaluate the use of a novel mode of ventilation known as Neurally adjusted ventilatory assist (NAVA) in infants with acute viral bronchiolitis.

The main aims are:

1. To determine whether an optimal combination of NAVA support level and Positive End Expiratory Pressure (PEEP) exists that can:

1. maximise aspects of respiratory muscle unloading and
2. minimize air trapping
2. To evaluate the impact of two morphine infusion doses on comfort levels and respiratory drive (standard = 20mcg/kg/hr, low = 5mcg/kg/hr) during ventilation titration.

Patients will act as their own control and will be randomly allocated to receive either standard or low dose morphine. They will receive the alternate dose on day 2. During each period of morphine dosing ventilation levels will be titrated and vital signs, respiratory parameters and comfort b scales will be recorded.

Conditions

  • Acute Viral Bronchiolitis

Interventions

DEVICE

Neurally Adjusted Ventilatory Assist

NAVA mode will be titrated as per protocol alongside titration of PEEP levels. Peep will be titrated for all NAVA levels in a descending order 10,5,0 NAVA level will be titrated in an ascending order 0.5, 1.0, 1.5, 2.0 at each PEEP level

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Shane Tibby · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2020-02-26
Completion
2020-02-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899894 on ClinicalTrials.gov