NAVA in Infants With Acute Viral Bronchiolitis: A Feasibility Study

NCT05899894 | Completed DMC

• 1 other identifier: 217195
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine whether an optimal combination of NAVA support level and Positive End Expiratory Pressure (PEEP) exists that can:
2. 2.maximise aspects of respiratory muscle unloading and
3. 3.minimize air trapping
4. 4.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.

Conditions

Acute Viral Bronchiolitis

Outcome Measures

Primary Outcomes (9)

• Changes to neuroventilatory efficiency when ventilation parameters are titrated

  Measured by a change in neuro-ventilatory efficiency (NVE) during titration of ventilation settings NVE is measured as a ratio between electrical activity of the diaphragm (Edi) and patient's tidal volume during inspiration (Edi/Tv). An improvement in NVE can be demonstrated by a decrease in Edi without a fall in Tv.

  Measures will be recorded during the intervention

• Changes to neuromuscular efficiency when ventilation parameters are titrated.

  Measured by a change neuro-muscular efficiency (NME) during changes in ventilation settings NME measures Edi against the generated airway pressure during an occlusion (P0.1) thus providing an estimate of inspiratory driving pressure normalized to inspiratory neural inspiratory effort. This will be presented as a ratio: Paw (airway pressure) - PEEP)/ Edi.

  Measures will be recorded during the intervention

• Changes to air trapping when ventilation parameters are titrated

  A forced deflation (FD) will require pressure to be applied to the thoracic area to mimic a forced exhalation - pressure loops will be recorded via the servo-i during this time. This will give an idea of forced vital capacity and the amount of airway resistance as FD causes dynamic compression of the airways. Residual volume will indicate level of air-trapping occurring. Forced Expiratory Volume (FEV) will be measured at the end of each PEEP level to assess the residual volume, a marker of air-trapping to assess whether PEEP titration overcomes intrinsic PEEP. This will be measured using a standardised physiotherapy technique. A large inflation breath (approx. 40cmH20) will be administered to the patient and held for 3 seconds followed by a manual compression, the ventilator will record flow loops from this compression - the degree of scalloping will be quantified in measuring the degree of air trapping using a validated calculation.

  Measures will be recorded immediately after each intervention

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

  Edi is a reflection of the electrical activity on the diaphragm. Normal Edi is 5-15 microvolts. There would be an expectation that this would change if the ventilation is meeting the patients ventilatory demands

  Measures will be recorded immediately after each intervention

• Maintenance of patient comfort

  Patient comfort will be measured using a COMFORT-Behavioral Scale (COMFORT-b). The COMFORT-b scale is an observational scale that has been validated for assessing comfort in children in PICU. Pain in children from 0-3 years of age and sedation in the 0-16 year old child. A score of 0-40 with a score greater than 22 indicating discomfort.

  Measures will be recorded immediately after each intervention

• Changes in blood pressure

  Changes to blood pressure will be recorded to ensure they are within normal range for the child's age.

  Measures will be recorded immediately after each intervention

• Changes in heart rate

  Changes to heart rate heart Rate recorded to ensure they are within normal range for the child's age.

  Measures will be recorded immediately after each intervention

• changes in respiratory rate

  Changes in respiratory rate will be recorded to ensure they are within normal range for the child's age.

  Measures will be recorded immediately after each intervention

• Stabilisation of vital signs

  Changes in transcutaneous carbon dioxide (TCO2) will be recorded to ensure they are within normal range for the child's age.

  Measures will be recorded immediately after each intervention

Secondary Outcomes (5)

• To assess recruitment rate

  On study completion up to 1 year

• To assess retention rates

  On study completion up to 1 year

• To assess time to recruit participants

  On study completion up to 1 year

• To record the incidence of adverse events

  On study completion up to 1 year

• To assess the willingness of clinicians to recruit participants

  On study completion up to 1 year

Study Arms (2)

A - Low dose morphine

ACTIVE COMPARATOR

Low dose morphine 5mcg/kg/hr

Device: Neurally Adjusted Ventilatory Assist

B- standard dose morphine

ACTIVE COMPARATOR

Standard dose morphine 20mcg/kg/hr

Device: Neurally Adjusted Ventilatory Assist

Interventions

Neurally Adjusted Ventilatory Assist DEVICE

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

A - Low dose morphine; B- standard dose morphine

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Shane Tibby

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will act as their own control. They will be randomised on day 1 to receive either standard dose or low dose morphine and on day two they will receive the alternate dose. Ventilation levels will be titrated as per a titration protocol.

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: June 12, 2023
• Study Start: November 5, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: June 12, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)