Acute Viral BronchiolitisNCT05899894
NAVA in Infants With Acute Viral Bronchiolitis: A Feasibility Study
A study testing Neurally Adjusted Ventilatory Assist in people with Acute Viral Bronchiolitis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- Neurally Adjusted Ventilatory Assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2019to 26 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Neurally Adjusted Ventilatory Assist (NAVA) Use in Infants With Acute Viral Bronchiolitis: a Randomised, Crossover Feasibility Study
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:
Read more
- To determine whether an optimal combination of NAVA support level and Positive End Expiratory Pressure (PEEP) exists that can:
- maximise aspects of respiratory muscle unloading and
- minimize air trapping
- 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.
Read the 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 (e.g. 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 (20mcg/kg/hr) and low dose morphine (5mcg/kg/hr). 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 parents/carers 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 (20mcg/kg/hr) or low dose morphine (5 mcg/kg/hr). These doses have been chosen to reflect current clinical practice and also using knowledge of morphine kinetics/dynamics 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 (comfort/pain 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 NAVA/PEEP titration periods (one per day) there is the potential for the child to experience changes in their comfort levels and/or 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.
- Conditions
- Acute Viral Bronchiolitis
- Being tested
- Neurally Adjusted Ventilatory Assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory AssistDevice
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
| Study group | Role | What they receive |
|---|---|---|
| A - Low dose morphine | Active comparator | Low dose morphine 5mcg/kg/hr Receives: Device: Neurally Adjusted Ventilatory Assist |
| B- standard dose morphine | Active comparator | Standard dose morphine 20mcg/kg/hr Receives: Device: Neurally Adjusted Ventilatory Assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measures will be recorded immediately after each intervention
Secondary outcomes (5)
To assess recruitment rate
Record recruitment rates of participants
Measured: On study completion up to 1 year
To assess retention rates
Record retention rates of participants
Measured: On study completion up to 1 year
To assess time to recruit participants
Record how long from admission it took to consent a participant into the study
Measured: On study completion up to 1 year
To record the incidence of adverse events
Recording of events as per Good Clinical Practice
Measured: On study completion up to 1 year
To assess the willingness of clinicians to recruit participants
Number approached and consented per clinician
Measured: On study completion up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start5 Nov 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane Tibby, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899894
- Sponsor's protocol ID
- 217195
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is not to share the raw data due to the exploratory nature of the study and the size of the individual data sets.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) Use in Infants With Acute Viral Bronchiolitis: a Randomised, Crossover Feasibility Study
- ClinicalTrials.gov ID
- NCT05899894
- Acronym / sponsor ID
- 217195
- Conditions
- Acute Viral Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine whether an optimal combination of NAVA support level and Positive End Expiratory Pressure (PEEP) exists that can:
- maximise aspects of respiratory muscle unloading and
- minimize air trapping
- 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.
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 (e.g. 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 (20mcg/kg/hr) and low dose morphine (5mcg/kg/hr). 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 parents/carers 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 (20mcg/kg/hr) or low dose morphine (5 mcg/kg/hr). These doses have been chosen to reflect current clinical practice and also using knowledge of morphine kinetics/dynamics 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 (comfort/pain 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 NAVA/PEEP titration periods (one per day) there is the potential for the child to experience changes in their comfort levels and/or 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A - Low dose morphine | Active comparator | Device: Neurally Adjusted Ventilatory AssistLow dose morphine 5mcg/kg/hr |
| B- standard dose morphine | Active comparator | Device: Neurally Adjusted Ventilatory AssistStandard dose morphine 20mcg/kg/hr |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurally Adjusted Ventilatory AssistNAVA 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 | Device | A - Low dose morphine, B- standard dose morphine |
Primary outcome
Changes to neuroventilatory efficiency when ventilation parameters are titrated
Time frame: Measures will be recorded during the intervention
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.
Changes to neuromuscular efficiency when ventilation parameters are titrated.
Time frame: Measures will be recorded during the intervention
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.
Changes to air trapping when ventilation parameters are titrated
Time frame: Measures will be recorded immediately after each intervention
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.
Change in Electrical activity of the diaphragm (Edi) when ventilator parameters are titrated
Time frame: Measures will be recorded immediately after each intervention
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
Maintenance of patient comfort
Time frame: Measures will be recorded immediately after each intervention
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.
Changes in blood pressure
Time frame: Measures will be recorded immediately after each intervention
Changes to blood pressure will be recorded to ensure they are within normal range for the child's age.
Changes in heart rate
Time frame: Measures will be recorded immediately after each intervention
Changes to heart rate heart Rate recorded to ensure they are within normal range for the child's age.
changes in respiratory rate
Time frame: Measures will be recorded immediately after each intervention
Changes in respiratory rate will be recorded to ensure they are within normal range for the child's age.
Stabilisation of vital signs
Time frame: Measures will be recorded immediately after each intervention
Changes in transcutaneous carbon dioxide (TCO2) will be recorded to ensure they are within normal range for the child's age.
5 secondary outcomes
To assess recruitment rate
Time frame: On study completion up to 1 year
To assess retention rates
Time frame: On study completion up to 1 year
To assess time to recruit participants
Time frame: On study completion up to 1 year
To record the incidence of adverse events
Time frame: On study completion up to 1 year
To assess the willingness of clinicians to recruit participants
Time frame: On study completion up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No. The plan is not to share the raw data due to the exploratory nature of the study and the size of the individual data sets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane Tibby principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally Adjusted Ventilatory Assist in people with Acute Viral Bronchiolitis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes to neuroventilatory efficiency when ventilation parameters are titrated (time frame: Measures will be recorded during the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.