Acute Respiratory FailureNCT02018666
Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.
A study testing NAVA endotracheal tube in people with Acute Respiratory Failure, run by Clinact at 11 sites in France.
Trial summary
This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- NAVA endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 11 sitesFrance
- Study dates
- Jan 2012to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ventilated with endotracheal tube for more than 24 hours
- Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
- Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
- Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
- Absence of administration of high-dose vasopressor therapy defined by:
- norepinephrine > 0.3 mcg / kg / min;
- dopamine > 10 mcg / kg / min;
- Estimated duration of mechanical ventilation > 48h00
Who cannot join
- Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
- Recent gastrointestinal suture ;
- Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
- Therapeutic limitation or active treatment discontinuation;
- Pregnant women;
- Minors;
- Protected adults;
- Patient already included in the study;
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hopital Larrey- CHU D'ANGERS
Angers, Maine Et Loire, 49933
Hopital PELLEGRIN
Bordeaux, Gironde, 33076
Hopital de la Cote de Nacre - CHU de CAEN
Caen, Normandy, 14000
Hopital d'Estaing
Clermont-Ferrand, Puy de Dome, 63100
Hôpital Dupuytren
Limoges, Haute Vienne, 87042
Hopital de la CROIX ROUSSE
Lyon, Auvergne-Rhône-Alpes, 69004
Centre Hospitalier Lyon Sud
Lyon, Auvergne-Rhône-Alpes, 69495
Hopital Saint-Eloi - CHU MONTPELLIER
Montpellier, Herault, 34295
Hopital L'Archet 1
Nice, Alpes Maritimes, 06202
Hôpital de la Pitié Salpetrière
Paris, Île-de-France Region, 75651
Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
Pessac, Gironde, 33604
About this study
Official title: ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).
This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.
- Conditions
- Acute Respiratory Failure
- Being tested
- NAVA endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA endotracheal tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| spontaneous NAVA mode | Experimental | Not described Receives: Device: NAVA endotracheal tube |
| Inspiratory pressure support (IPS) | Active comparator | Not described Receives: Device: NAVA endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
Measured: Continuous recording during 48 hours following the intubation
Secondary outcomes (5)
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
Measured: Continuous recording during the first 48 hours
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode
Measured: Continuous recording during the first 48 hours
Earnings on the "breathing comfort"
Measured: Continuous recording during the first 48 hours
Earnings on sleep architecture
Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep.
Measured: Continuous recording during the first 48 hours
Tolerance
- Adverse events associated with the use of the device.
- Incidence of ventilator-acquired pneumonia.
- Duration of ICU stay.
- Duration of hospital stay.
- Mortality in the ICU.
- Hospital mortality.
Measured: Continuous for the duration of ICU stay, an expected maximum of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinact
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018666
- Sponsor's protocol ID
- N° 2011-001
- Other IDs
- 2011-A00559-32
- Status last verified
- Dec 2013
- First submitted
- 11 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
Publications
Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30.
PubMed 27686347
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).
- ClinicalTrials.gov ID
- NCT02018666
- Acronym / sponsor ID
- N° 2011-001
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- ClinactUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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 is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spontaneous NAVA mode | Experimental | Device: NAVA endotracheal tube |
| Inspiratory pressure support (IPS) | Active comparator | Device: NAVA endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient ventilated with endotracheal tube for more than 24 hours
- Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
- Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
- Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
- Absence of administration of high-dose vasopressor therapy defined by:
Key exclusion criteria (8 listed)
- Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
- Therapeutic limitation or active treatment discontinuation;
- Pregnant women;
- Minors;
- Protected adults;
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 |
|---|---|---|
| NAVA endotracheal tube | Device | Inspiratory pressure support (IPS), spontaneous NAVA mode |
Primary outcome
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
Time frame: Continuous recording during 48 hours following the intubation
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
5 secondary outcomes
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
Time frame: Continuous recording during the first 48 hours
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
Time frame: Continuous recording during the first 48 hours
Earnings on the "breathing comfort"
Time frame: Continuous recording during the first 48 hours
Earnings on sleep architecture
Time frame: Continuous recording during the first 48 hours
Tolerance
Time frame: Continuous for the duration of ICU stay, an expected maximum of 14 days
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 23 Dec 2013.
- Derived from this study: PubMed 27686347Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA endotracheal tube in people with Acute Respiratory Failure, run by Clinact at 11 sites 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 8 inclusion and 8 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 23 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion. (time frame: Continuous recording during 48 hours following the intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018666, which also lists 1 linked publication.
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 23 Dec 2013.