Infantile Spinal Muscular AtrophyNAVASINCT03395795
Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
A study testing NAVA in people with Infantile Spinal Muscular Atrophy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Infantile Spinal Muscular Atrophy
- What is being tested?
- NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 5 Oct 2021
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age above 1 year and under 18 years
- Patient hospitalized in the pediatric intensive care unit.
- Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
- Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
- Affiliation to the French health insurance organism
- Consent signed by the two holders of parental authority for the child participation in the research.
Who cannot join
- Contraindications to the use of NAVA or the setting up of a nasogastric tube.
- Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
- Severe respiratory instability requiring imminent intubation or FiO2> 60%, or PaCO2> 80 mmHg.
- Limitation of life support treatments discussed or decided.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de pédiatrie, Hôpital Raymond Poincaré
Garches, Hauts-de-Seine, 92380
About this study
Official title: Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.
To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.
Read the detailed description
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.
- Conditions
- Infantile Spinal Muscular Atrophy
- Being tested
- NAVA
- Keywords
- Infantile Spinal Muscular Atrophy, Respiratory Decompensations
- Medical subject headings
- Spinal Muscular Atrophies of Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVADevice
The study has 3 phases:
- Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements.
- Phase 2: Switch to NAVA mode (1h).
- Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode.
- NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min.
- Phase 3:
The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation. Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony percentage
Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.
Measured: At baseline
Secondary outcomes (7)
Feasibility
Frequency of obtaining an EADi signal
Measured: At baseline
Feasibility
Percentage of effective time spent in activated NAVA mode
Measured: At baseline
Efficacy and tolerance
Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.
Measured: At 30 minutes and 60 minutes
Efficacy and tolerance
Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.
Measured: At 30 minutes and 60 minutes
Efficacy and tolerance
O2 saturation will be collected.
Measured: At 30 minutes and 60 minutes
Efficacy and tolerance
FiO2 after 30 and 60 minutes under each ventilation mode will be collected.
Measured: At 30 minutes and 60 minutes
Rate of recourse to intubation
Rate of recourse to intubation, patient preference.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start13 Feb 2018
- Primary completion17 Dec 2019
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile Spinal Muscular AtrophyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aben Essid, MD, Study chair, Service de pédiatrie, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395795
- Sponsor's protocol ID
- P160941J
- Other IDs
- IDRCB 2017-A02785-48
- Acronym
- NAVASI
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
- ClinicalTrials.gov ID
- NCT03395795
- Acronym / sponsor ID
- NAVASI / P160941J
- Conditions
- Infantile Spinal Muscular Atrophy
- Keywords
- Infantile Spinal Muscular Atrophy, Respiratory Decompensations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 10 Jan 2018 (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.
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.
To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.
Detailed description
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: NAVASingle arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age above 1 year and under 18 years
- Patient hospitalized in the pediatric intensive care unit.
- Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
- Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
- Affiliation to the French health insurance organism
Key exclusion criteria (4 listed)
- Contraindications to the use of NAVA or the setting up of a nasogastric tube.
- Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
- Severe respiratory instability requiring imminent intubation or FiO2> 60%, or PaCO2> 80 mmHg.
- Limitation of life support treatments discussed or decided.
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 |
|---|---|---|
| NAVAThe study has 3 phases: 1. Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements. 2. Phase 2: Switch to NAVA mode (1h). * Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode. * NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min. 3. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording. | Device | Single arm |
Primary outcome
Asynchrony percentage
Time frame: At baseline
Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.
7 secondary outcomes
Feasibility
Time frame: At baseline
Feasibility
Time frame: At baseline
Efficacy and tolerance
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
Time frame: At 30 minutes and 60 minutes
Efficacy and tolerance
Time frame: At 30 minutes and 60 minutes
Rate of recourse to intubation
Time frame: At baseline
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 29 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Aben Essid, MD study chair
Service de pédiatrie, Hôpital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA in people with Infantile Spinal Muscular Atrophy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 4 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 29 Mar 2022. 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 France. 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?
Asynchrony percentage (time frame: At baseline). 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 29 Mar 2022.