Acute Respiratory FailureNCT01730794
Neurally Adjusted Ventilatory Assist (NAVA) Study in Adults With Acute Respiratory Failure
A study testing NAVA ventilation and Conventional Lung Protective Ventilation in people with Acute Respiratory Failure, run by Massachusetts General Hospital at 14 sites in 2 countries.
Trial summary
The purpose of this study is to compare a specific mode of artificial ventilation (help from a breathing machine) with other modes. This specific mode is called Neurally Adjusted Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from the diaphragm (breathing muscle) to help patients… 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 ventilation and Conventional Lung Protective Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 28 Mar 2014to 22 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Hypoxemic or hypercapnic acute respiratory failure
- Intubation and mechanical ventilation
- Anticipated mechanical ventilation equal or longer than 72 hrs
- Mechanically ventilated less or equal to 5 days
- Able to spontaneously trigger the ventilator
Who cannot join
- moderate-to-severe acute respiratory distress syndrome
- Post-operative patient's normally requiring a short course of mechanical ventilation (for example most cardiac surgical patients)
- Unable to spontaneously breathe
- Need to provide controlled ventilation
- Poor short term prognosis (defined as a high risk of death in the next 3 months)
- Neuromuscular or neurologic disease
Show all 11Show fewer
- Age < 18 years
- Patients with major esophageal, gastric and oral surgery
- Acute brain injury or elevated intracranial pressure (> 18 mmHg)
- Severe cardiac disease: New York Heart Association class 3 or 4 or acute coronary syndrome or persistent ventricular tachyarrhythmias.
- Pregnancy, must be confirmed by laboratory analysis.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Spain13 sites
Complejo Hospitalario Universitario de Albacete
Albacete, 02006
Hospital Virgen de la Luz
Cuenca, 16002
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Morales Meseguer
Murcia, 30008
Hospital Universitario Virgen de Arrixaca
Murcia, 30120
Hospital Universitario NS de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital NS del Prado
Talavera de la Reina, Toledo, 45600
Hospital Virgen de la Salud
Toledo, 45004
Hospital Clinico de Valencia
Valencia
Hospital Universitario Rio Hortega
Valladolid, 47012
Hospital Txagorritxu
Vitoria-Gasteiz, Álava, 01007
About this study
Official title: A Comparative, Multicenter, Randomized, Controlled Study of Neurally Adjusted Ventilatory Assist (NAVA) vs. Conventional Lung Protective Ventilation in Patients With Acute Respiratory Failure
The purpose of this study is to compare a specific mode of artificial ventilation (help from a breathing machine) with other modes. This specific mode is called Neurally Adjusted Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from the diaphragm (breathing muscle) to help patients breathe. The investigators believe that using these signals, NAVA can determine the exact timing for patients' spontaneous breathing effort and delivers the artificial breath at the same time (in synchrony) with their own breath. Other modes (breathing methods) may cause asynchrony between the patient and the ventilator while delivering artificial breaths because of the way they operate. Asyncrony between patient and ventilator is a risk factor for increasing the length of artificial ventilation and number of related complications. The investigators would like to find out if NAVA performs better in establishing synchrony between patient and ventilator and as a result decreasing time for artificial ventilation and increasing better outcomes.
Read the detailed description
Study Goal To compare the ability of NAVA vs. conventional lung protective ventilation in a multicenter, unblinded, randomized, controlled fashion to provide invasive ventilatory support during acute respiratory failure in adults who are expected to require ventilatory support for greater than 72 hours.
Hypothesis It is hypothesized that the use of NAVA compared to conventional lung protective ventilation will result in a decrease in the number of days of mechanical ventilation. It is further hypothesized that NAVA compared to conventional lung protective ventilation will result in a decrease in the length of weaning, the length of ICU and hospital stay, and mortality.
Primary Outcome
- Number of invasive ventilator free days.
Secondary Outcome
- Mortality
- Length of Invasive Ventilation in survivors
- Length of ICU and hospital stay
- Incidence of barotrauma (defined as the presence of any extra-pulmonary air that was not present at study enrollment).
- Ventilator associated pneumonia (development of a pneumonia 48 hrs after entry into the study).
- Development of ARDS (after enrollment into the study; defined as a rapid onset, a P/F<200 mmHg, and bilateral pulmonary infiltrates that are not of cardiac origin).
- Conditions
- Acute Respiratory Failure
- Being tested
- NAVA ventilation, Conventional Lung Protective Ventilation
- Keywords
- Acute Respiratory Failure, Mechanical Ventilation, NAVA, Lung protective ventilation, invasive ventilation, noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA ventilationOther
Neurally adjusted ventilatory assist
Conventional Lung Protective VentilationOther
conventional protective mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Conventional Lung Protective Ventilation | Other | In this group, patients will be ventilated in either volume A/C, pressure A/C, pressure support, pressure regulated volume control or volume support based on the discretion of the medical team with TV 4-8 ml/kg PBW range and PP or pressure (control or support) level <30 cmH2O. Receives: Other: Conventional Lung Protective Ventilation |
| NAVA Ventilation Group | Other | In the NAVA group, NAVA level will be set initially at zero, then the maximum Edi will be determined as the average level over the next 3 to 5 breaths without ventilatory support or PEEP. The actual NAVA level will then be titrated by the clinician to achieve the following: 1) an Edi equal to approximately 50% of the maximum Edi, 2) an average tidal volume of between 4 to 8 ml/kg predicted body weight (PBW), and 3) an average respiratory rate between about 15 and 40 per minute. In addition, the trigger sensitivity should be set as sensitive as possible without causing auto-triggering and the maximum pressure limit in NAVA should be set at 40 cm H2O. Receives: Other: NAVA ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of invasive ventilator free days.
Number of days without mechanical ventilation, within the first 28 days of the study.
Measured: 28 days
Secondary outcomes (7)
Total length of mechanical ventilation in survivors (invasive plus noninvasive)
Total number of days of mechanical ventilation in ICU survivors.
Measured: 90 days
ICU and hospital Mortality
Mortality during patient stay in the ICU and after being discharged from ICU
Measured: 90 days
Incidence of barotrauma
Number of diagnosed pneumothorax
Measured: 60 Days
Ventilator associated pneumonia
Number of diagnosed Ventilator Associated Pneumonia
Measured: 60 Days
Development of Acute respiratory distress syndrome (ARDS)
Number of patients developing ARDS
Measured: 60 Days
Length of ICU stay
Total number of days of ICU stay.
Measured: 90 Days
Length of hospital stay
Total number of days of Hospital stay.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start28 Mar 2014
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
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.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Gran Canaria Doctor Negrín
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert M Kacmarek, PhD, Principal investigator, Massachusetts General HospitalJesus Villar, MD, PhD, Principal investigator, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730794
- Sponsor's protocol ID
- 2012P002419
- Status last verified
- Jan 2020
- First submitted
- 15 Nov 2012
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Villar J, Belda J, Blanco J, Suarez-Sipmann F, Anon JM, Perez-Mendez L, Ferrando C, Parrilla D, Montiel R, Corpas R, Gonzalez-Higueras E, Pestana D, Martinez D, Fernandez L, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; NAVa In Acute respiraTORy failure (NAVIATOR) Network. Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):500. doi: 10.1186/s13063-016-1625-5.
PubMed 27737690
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Multicenter, Randomized, Controlled Study of Neurally Adjusted Ventilatory Assist (NAVA) vs. Conventional Lung Protective Ventilation in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT01730794
- Acronym / sponsor ID
- 2012P002419
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute Respiratory Failure, Mechanical Ventilation, NAVA, Lung protective ventilation, invasive ventilation, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Hospital Universitario de Gran Canaria Doctor Negrín
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 21 Nov 2012 (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.
The purpose of this study is to compare a specific mode of artificial ventilation (help from a breathing machine) with other modes. This specific mode is called Neurally Adjusted Ventilatory Assist (NAVA) and is different from other modes as it uses direct signals from the diaphragm (breathing muscle) to help patients breathe. The investigators believe that using these signals, NAVA can determine the exact timing for patients' spontaneous breathing effort and delivers the artificial breath at the same time (in synchrony) with their own breath. Other modes (breathing methods) may cause asynchrony between the patient and the ventilator while delivering artificial breaths because of the way they operate. Asyncrony between patient and ventilator is a risk factor for increasing the length of artificial ventilation and number of related complications. The investigators would like to find out if NAVA performs better in establishing synchrony between patient and ventilator and as a result decreasing time for artificial ventilation and increasing better outcomes.
Detailed description
Study Goal To compare the ability of NAVA vs. conventional lung protective ventilation in a multicenter, unblinded, randomized, controlled fashion to provide invasive ventilatory support during acute respiratory failure in adults who are expected to require ventilatory support for greater than 72 hours.
Hypothesis It is hypothesized that the use of NAVA compared to conventional lung protective ventilation will result in a decrease in the number of days of mechanical ventilation. It is further hypothesized that NAVA compared to conventional lung protective ventilation will result in a decrease in the length of weaning, the length of ICU and hospital stay, and mortality.
Primary Outcome
- Number of invasive ventilator free days.
Secondary Outcome
- Mortality
- Length of Invasive Ventilation in survivors
- Length of ICU and hospital stay
- Incidence of barotrauma (defined as the presence of any extra-pulmonary air that was not present at study enrollment).
- Ventilator associated pneumonia (development of a pneumonia 48 hrs after entry into the study).
- Development of ARDS (after enrollment into the study; defined as a rapid onset, a P/F<200 mmHg, and bilateral pulmonary infiltrates that are not of cardiac origin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Lung Protective Ventilation | Other | Other: Conventional Lung Protective VentilationIn this group, patients will be ventilated in either volume A/C, pressure A/C, pressure support, pressure regulated volume control or volume support based on the discretion of the medical team with TV 4-8 ml/kg PBW range and PP or pressure (control or support) level <30 cmH2O. |
| NAVA Ventilation Group | Other | Other: NAVA ventilationIn the NAVA group, NAVA level will be set initially at zero, then the maximum Edi will be determined as the average level over the next 3 to 5 breaths without ventilatory support or PEEP. The actual NAVA level will then be titrated by the clinician to achieve the following: 1) an Edi equal to approximately 50% of the maximum Edi, 2) an average tidal volume of between 4 to 8 ml/kg predicted body weight (PBW), and 3) an average respiratory rate between about 15 and 40 per minute. In addition, the trigger sensitivity should be set as sensitive as possible without causing auto-triggering and the maximum pressure limit in NAVA should be set at 40 cm H2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Hypoxemic or hypercapnic acute respiratory failure
- Intubation and mechanical ventilation
- Anticipated mechanical ventilation equal or longer than 72 hrs
- Mechanically ventilated less or equal to 5 days
Key exclusion criteria (11 listed)
- moderate-to-severe acute respiratory distress syndrome
- Post-operative patient's normally requiring a short course of mechanical ventilation (for example most cardiac surgical patients)
- Unable to spontaneously breathe
- Need to provide controlled ventilation
- Poor short term prognosis (defined as a high risk of death in the next 3 months)
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 ventilationNeurally adjusted ventilatory assist | Other | NAVA Ventilation Group |
| Conventional Lung Protective Ventilationconventional protective mechanical ventilation | Other | Conventional Lung Protective Ventilation |
Primary outcome
Number of invasive ventilator free days.
Time frame: 28 days
Number of days without mechanical ventilation, within the first 28 days of the study.
7 secondary outcomes
Total length of mechanical ventilation in survivors (invasive plus noninvasive)
Time frame: 90 days
ICU and hospital Mortality
Time frame: 90 days
Incidence of barotrauma
Time frame: 60 Days
Ventilator associated pneumonia
Time frame: 60 Days
Development of Acute respiratory distress syndrome (ARDS)
Time frame: 60 Days
Length of ICU stay
Time frame: 90 Days
Length of hospital stay
Time frame: 90 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 27 Jan 2020.
- Derived from this study: PubMed 27737690Villar J, Belda J, Blanco J, Suarez-Sipmann F, Anon JM, Perez-Mendez L, Ferrando C, Parrilla D, Montiel R, Corpas R, Gonzalez-Higueras E, Pestana D, Martinez D, Fernandez L, Soro M, Garcia-Bello MA, Fernandez RL, Kacmarek RM; NAVa In Acute respiraTORy failure (NAVIATOR) Network. Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):500. doi: 10.1186/s13063-016-1625-5.
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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.
Robert M Kacmarek, PhD principal investigator
Massachusetts General Hospital
Jesus Villar, MD, PhD principal investigator
Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA ventilation and Conventional Lung Protective Ventilation in people with Acute Respiratory Failure, run by Massachusetts General Hospital at 14 sites in 2 countries.
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 11 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, China. 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?
Number of invasive ventilator free days. (time frame: 28 days). 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 NCT01730794, 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 27 Jan 2020.