Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899894
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2022-12-08
Brief Title:
NAVA in Infants With Acute Viral Bronchiolitis A Feasibility Study
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Neurally Adjusted Ventilatory Assist NAVA Use in Infants With Acute Viral Bronchiolitis a Randomised Crossover Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 20mcgkghr low 5mcgkghr 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
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 20mcgkghr low 5mcgkghr 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
Detailed Description:
This study is a Randomised non-blinded crossover morphine dose mode of ventilation feasibility study to evaluate the use of NAVA in infants with acute viral bronchiolitis
Background and study aims
This study aims to evaluate a novel mode of mechanical ventilation breathing machine Neurally Adjusted Ventilatory Assist NAVA in infants admitted to the paediatric intensive care unit PICU with acute viral bronchiolitis This respiratory illness accounts for 12 of PICU admissions nationally Current modes of ventilation are inefficient often requiring prolonged use of sedative drugs for comfort and to improve ease of ventilation synchronicity Consequences of prolonged sedative use are muscle wastage including the respiratory muscles increased risk of developing secondary infections and the potential for withdrawal from medication symptoms
NAVA is a mode of ventilation that is delivered using our current ventilators breathing machines However it differs from current modes by providing respiratory support in proportion to the signal from the brain to move the diaphragm this is achieved via measurement of electrical activity of the diaphragm the main muscle used to initiate a breath This is measured by using a modified version of the patients feeding tube which is used in PICU to feed patients whilst on a ventilator
Research in children to date has demonstrated that NAVA compared to other ventilatory modes allows for improved ventilator synchrony reduced work of breathing and potentially less sedative use This is consistent with our clinical impression we have been using NAVA in an ad hoc way for 5 years Although some of these studies included infants with bronchiolitis the findings were not specific to this patient group Of note we do not yet know how to optimise NAVA settings in bronchiolitis and whether current common sedative drugs eg morphine affect this by decreasing respiratory drive excessively potentially compromising NAVA utility
We will evaluate how to optimise NAVA settings when compared to conventional ventilation in infants with acute viral bronchiolitis admitted to PICU A range of NAVA settings will be systematically evaluated over two periods on consecutive days maximum 4 hours per period per day Observation of the effects of different levels of NAVA support on synchronicity work of breathing and changes in physiological parameters will take place Patients will also receive 2 different adjustments to their morphine infusions in random order on the consecutive days standard dose morphine 20mcgkghr and low dose morphine 5mcgkghr Both morphine doses are within the range currently used clinically Patient comfort will be assessed frequently throughout and the effects of morphine on diaphragmatic neural activity will be recorded
Who can participate
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
What does the study involve
Within 48 hours parentscarers of patients admitted with a primary diagnosis of acute viral bronchiolitis who meet the inclusion criteria will be approached by a member of the direct healthcare team and invited to take part in the study The pre-existing feeding tubes will be replaced with NAVA catheters by the bedside nurse or research team Ventilation modes will be titrated on 2 consecutive days accompanied by two different Morphine doses delivered to the participant in random order Participants will be randomised to receive either standard dose morphine 20mcgkghr or low dose morphine 5 mcgkghr These doses have been chosen to reflect current clinical practice and also using knowledge of morphine kineticsdynamics on infant respiratory drive
Ventilation titration involves changes in NAVA level which increase over time and changes in PEEP which decrease over time to assess the ventilator setting that the patient responds to in terms of the outcome measures This will enable identification of the optimum ventilation strategy for that participant Titration will occur over time on 2 consecutive days as outlined above There will be a wash in period of 5-10 minutes for each change in ventilator setting and a period of 5 minutes when the recordings of the outcome measures will take place
Baseline recordings will be taken for current ventilator settings vital signs and respiratory measures and COMFORT-behavioral scale comfortpain scale Study procedures will be timed to accommodate routine care such as daily physiotherapy sessions
Benefits and risks
Due to changes in ventilation settings during the two NAVAPEEP titration periods one per day there is the potential for the child to experience changes in their comfort levels andor physiological parameters These will be continuously monitored by the researchers and the clinical bedside team If the patient experiences discomfort during the study period as expressed by a COMFORT-b the patient will be returned to the previous ventilator settings and the reasons for discomfort will be assessed Pain and sedation guidance will be adhered to as per usual care
Background and study aims
This study aims to evaluate a novel mode of mechanical ventilation breathing machine Neurally Adjusted Ventilatory Assist NAVA in infants admitted to the paediatric intensive care unit PICU with acute viral bronchiolitis This respiratory illness accounts for 12 of PICU admissions nationally Current modes of ventilation are inefficient often requiring prolonged use of sedative drugs for comfort and to improve ease of ventilation synchronicity Consequences of prolonged sedative use are muscle wastage including the respiratory muscles increased risk of developing secondary infections and the potential for withdrawal from medication symptoms
NAVA is a mode of ventilation that is delivered using our current ventilators breathing machines However it differs from current modes by providing respiratory support in proportion to the signal from the brain to move the diaphragm this is achieved via measurement of electrical activity of the diaphragm the main muscle used to initiate a breath This is measured by using a modified version of the patients feeding tube which is used in PICU to feed patients whilst on a ventilator
Research in children to date has demonstrated that NAVA compared to other ventilatory modes allows for improved ventilator synchrony reduced work of breathing and potentially less sedative use This is consistent with our clinical impression we have been using NAVA in an ad hoc way for 5 years Although some of these studies included infants with bronchiolitis the findings were not specific to this patient group Of note we do not yet know how to optimise NAVA settings in bronchiolitis and whether current common sedative drugs eg morphine affect this by decreasing respiratory drive excessively potentially compromising NAVA utility
We will evaluate how to optimise NAVA settings when compared to conventional ventilation in infants with acute viral bronchiolitis admitted to PICU A range of NAVA settings will be systematically evaluated over two periods on consecutive days maximum 4 hours per period per day Observation of the effects of different levels of NAVA support on synchronicity work of breathing and changes in physiological parameters will take place Patients will also receive 2 different adjustments to their morphine infusions in random order on the consecutive days standard dose morphine 20mcgkghr and low dose morphine 5mcgkghr Both morphine doses are within the range currently used clinically Patient comfort will be assessed frequently throughout and the effects of morphine on diaphragmatic neural activity will be recorded
Who can participate
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
What does the study involve
Within 48 hours parentscarers of patients admitted with a primary diagnosis of acute viral bronchiolitis who meet the inclusion criteria will be approached by a member of the direct healthcare team and invited to take part in the study The pre-existing feeding tubes will be replaced with NAVA catheters by the bedside nurse or research team Ventilation modes will be titrated on 2 consecutive days accompanied by two different Morphine doses delivered to the participant in random order Participants will be randomised to receive either standard dose morphine 20mcgkghr or low dose morphine 5 mcgkghr These doses have been chosen to reflect current clinical practice and also using knowledge of morphine kineticsdynamics on infant respiratory drive
Ventilation titration involves changes in NAVA level which increase over time and changes in PEEP which decrease over time to assess the ventilator setting that the patient responds to in terms of the outcome measures This will enable identification of the optimum ventilation strategy for that participant Titration will occur over time on 2 consecutive days as outlined above There will be a wash in period of 5-10 minutes for each change in ventilator setting and a period of 5 minutes when the recordings of the outcome measures will take place
Baseline recordings will be taken for current ventilator settings vital signs and respiratory measures and COMFORT-behavioral scale comfortpain scale Study procedures will be timed to accommodate routine care such as daily physiotherapy sessions
Benefits and risks
Due to changes in ventilation settings during the two NAVAPEEP titration periods one per day there is the potential for the child to experience changes in their comfort levels andor physiological parameters These will be continuously monitored by the researchers and the clinical bedside team If the patient experiences discomfort during the study period as expressed by a COMFORT-b the patient will be returned to the previous ventilator settings and the reasons for discomfort will be assessed Pain and sedation guidance will be adhered to as per usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None