CompletedNot Applicable

NAVA in Infants With Acute Viral Bronchiolitis: A Feasibility Study

United Kingdom16 participantsStarted 2019-11-05

Plain-language 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.

Who can participate

Age range1 Day – 1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants aged \> 36 weeks corrected gestation and \< 1 year of age * Admitted to PICU with acute viral bronchiolitis within 48 hours of admission * Likely to require mechanical ventilation for \> 24 hours after enrolment * Able to pass a nasogastric tube Exclusion Criteria: * Apnoea as a primary reason for ventilation in the absence of respiratory symptoms * History of gastro-intestinal bleeds in previous 30 days or significant coagulopathy * Facial trauma or surgery * Known neuro-muscular disease or diaphragmatic palsy * Haemodynamic instability (requiring inotropes)

What they're measuring

Changes to neuroventilatory efficiency when ventilation parameters are titrated

Timeframe: Measures will be recorded during the intervention

Changes to neuromuscular efficiency when ventilation parameters are titrated.

Timeframe: Measures will be recorded during the intervention

Changes to air trapping when ventilation parameters are titrated

Timeframe: Measures will be recorded immediately after each intervention

Change in Electrical activity of the diaphragm (Edi) when ventilator parameters are titrated

Timeframe: Measures will be recorded immediately after each intervention

Maintenance of patient comfort

Timeframe: Measures will be recorded immediately after each intervention

Changes in blood pressure

Timeframe: Measures will be recorded immediately after each intervention

Changes in heart rate

Timeframe: Measures will be recorded immediately after each intervention

Trial details

NCT IDNCT05899894

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-26

View on ClinicalTrials.gov More Acute Viral Bronchiolitis trials