Acute Respiratory Distress SyndromeNCT01519258
Mechanical Ventilation With Neurally-Adjusted Ventilatory Assist in Patients With ARDS
A study testing Pressure Support ventilation and NAVA in people with Acute Respiratory Distress Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical activity of the diaphragm to control the mechanical ventilator, offering inspiratory assistance in proportion to respiratory effort to patients who need artificial ventilatory support. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Pressure Support ventilation and NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Dec 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation for more than 24 hours;
- Diagnosis of ARDS
- Clinical indication of lung protective mechanical ventilation by the ICU team;
- Presence of active inspiratory efforts for more than 6 hours
Who cannot join
- Patients under 18 years;
- Pregnant women;
- Trauma or burns of the face that hinder the passage of gastro-esophageal catheter;
- Nasal pathologies that prevent the progression of gastro-esophageal catheter;
- Ulcers of the esophagus or stomach;
- Documented esophageal varices;
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- Tracheostomized patients;
- Instability of the chest wall or diaphragmatic injury;
- Hemodynamic instability, defined as the need to increase vasoactive drugs in the last two hours in order to maintain the mean arterial pressure above 60 mmHg).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05403-010
About this study
Official title: Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical activity of the diaphragm to control the mechanical ventilator, offering inspiratory assistance in proportion to respiratory effort to patients who need artificial ventilatory support. It has been shown to improve the interaction between the patient and the mechanical ventilator in several clinical situations, but no previous studies have tried to use it for patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS benefit from a mechanical ventilatory strategy that includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the application of such strategy frequently requires high levels of sedation. The investigators' hypothesis is that NAVA can be used for patients with ARDS, and that it will not be associated with excessive tidal volumes or elevated airway pressures.
Read the detailed description
Neurally Adjusted ventilatory-Assist(NAVA) is an assisted ventilatory mode that captures the electrical activity of the diaphragm and uses it to initiate and terminate the inspiratory phase, offering inspiratory assistance in proportion to patient effort, cycle by cycle. Studies in animals and humans have shown that NAVA reduces the work of breathing and improves patient-ventilator interaction in comparison with traditional modes. Because it is an assisted mode, its use requires less sedation.
The use of NAVA could contribute to the reduction of complications of prolonged mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) submitted to protective ventilation with low tidal volumes and limited plateau pressure. However, there are no studies with NAVA in the acute phase of ARDS, in which assisted-controlled modes are generally used, allowing for adjustment of tidal volume and/or plateau pressure.
With this project, the investigators intend to evaluate the behavior of NAVA mode in the acute phase of mechanical ventilation in ARDS patients, to assess whether this mode can be used to deliver an assisted lung protective ventilation strategy.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Pressure Support ventilation, NAVA
- Keywords
- ARDS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Support ventilationOther
Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.
NAVADevice
Patients will be ventilated with NAVA for 15 minutes. Back up settings in pressure support mode will be set in case the esophageal catheter is misplaced, and back up settings in pressure control ventilation will be set in case no inspiratory efforts are detected for longer than 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| PSV | Active comparator | Patients will be ventilated with the a conventional mode of ventilation called Pressure Support Ventilation (PSV) for 15 minutes. Mechanical ventilator settings will be set to match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations. Receives: Other: Pressure Support ventilation |
| NAVA | Experimental | Patients will be ventilated with NAVA for 15 minutes. Nava level will be titrated prior to randomization, to deliver the same peak of airway pressure obtained with the active comparator, PSV. The resulting tidal volume should match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations. Receives: Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume will be recorded breath by breath for 15 minutes
Measured: 15 min
Secondary outcomes (2)
respiratory rate
Respiratory rate will be recorded breath by breath for 15 minutes
Measured: 15 min
Prolonged NAVA ventilation
patients will be kept on NAVA for three hours after the first part of the protocol, to evaluate the feasibility of ventilating these patients with NAVA for prolonged periods
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2015
- Study completionDec 2015
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 Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Juliana C Ferreira, M.D., Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519258
- Sponsor's protocol ID
- 2011/20225-1 FAPESP
- Status last verified
- Apr 2019
- First submitted
- 7 Dec 2011
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Diniz-Silva F, Moriya HT, Alencar AM, Amato MBP, Carvalho CRR, Ferreira JC. Neurally adjusted ventilatory assist vs. pressure support to deliver protective mechanical ventilation in patients with acute respiratory distress syndrome: a randomized crossover trial. Ann Intensive Care. 2020 Feb 10;10(1):18. doi: 10.1186/s13613-020-0638-0.
PubMed 32040785
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01519258
- Acronym / sponsor ID
- 2011/20225-1 FAPESP
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Oct 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jan 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.
Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical activity of the diaphragm to control the mechanical ventilator, offering inspiratory assistance in proportion to respiratory effort to patients who need artificial ventilatory support. It has been shown to improve the interaction between the patient and the mechanical ventilator in several clinical situations, but no previous studies have tried to use it for patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS benefit from a mechanical ventilatory strategy that includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the application of such strategy frequently requires high levels of sedation. The investigators' hypothesis is that NAVA can be used for patients with ARDS, and that it will not be associated with excessive tidal volumes or elevated airway pressures.
Detailed description
Neurally Adjusted ventilatory-Assist(NAVA) is an assisted ventilatory mode that captures the electrical activity of the diaphragm and uses it to initiate and terminate the inspiratory phase, offering inspiratory assistance in proportion to patient effort, cycle by cycle. Studies in animals and humans have shown that NAVA reduces the work of breathing and improves patient-ventilator interaction in comparison with traditional modes. Because it is an assisted mode, its use requires less sedation.
The use of NAVA could contribute to the reduction of complications of prolonged mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) submitted to protective ventilation with low tidal volumes and limited plateau pressure. However, there are no studies with NAVA in the acute phase of ARDS, in which assisted-controlled modes are generally used, allowing for adjustment of tidal volume and/or plateau pressure.
With this project, the investigators intend to evaluate the behavior of NAVA mode in the acute phase of mechanical ventilation in ARDS patients, to assess whether this mode can be used to deliver an assisted lung protective ventilation strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSV | Active comparator | Other: Pressure Support ventilationPatients will be ventilated with the a conventional mode of ventilation called Pressure Support Ventilation (PSV) for 15 minutes. Mechanical ventilator settings will be set to match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations. |
| NAVA | Experimental | Device: NAVAPatients will be ventilated with NAVA for 15 minutes. Nava level will be titrated prior to randomization, to deliver the same peak of airway pressure obtained with the active comparator, PSV. The resulting tidal volume should match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mechanical ventilation for more than 24 hours;
- Diagnosis of ARDS
- Clinical indication of lung protective mechanical ventilation by the ICU team;
- Presence of active inspiratory efforts for more than 6 hours
Key exclusion criteria (9 listed)
- Patients under 18 years;
- Pregnant women;
- Trauma or burns of the face that hinder the passage of gastro-esophageal catheter;
- Nasal pathologies that prevent the progression of gastro-esophageal catheter;
- Ulcers of the esophagus or stomach;
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 |
|---|---|---|
| Pressure Support ventilationPatients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used. | Other | PSV |
| NAVAPatients will be ventilated with NAVA for 15 minutes. Back up settings in pressure support mode will be set in case the esophageal catheter is misplaced, and back up settings in pressure control ventilation will be set in case no inspiratory efforts are detected for longer than 15 seconds | Device | NAVA |
Primary outcome
Tidal volume
Time frame: 15 min
Tidal volume will be recorded breath by breath for 15 minutes
2 secondary outcomes
respiratory rate
Time frame: 15 min
Prolonged NAVA ventilation
Time frame: 3 hours
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 3 Apr 2019.
- Derived from this study: PubMed 32040785Diniz-Silva F, Moriya HT, Alencar AM, Amato MBP, Carvalho CRR, Ferreira JC. Neurally adjusted ventilatory assist vs. pressure support to deliver protective mechanical ventilation in patients with acute respiratory distress syndrome: a randomized crossover trial. Ann Intensive Care. 2020 Feb 10;10(1):18. doi: 10.1186/s13613-020-0638-0.
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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.
Juliana C Ferreira, M.D. principal investigator
University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Support ventilation and NAVA in people with Acute Respiratory Distress Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 9 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 3 Apr 2019. 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 Brazil. 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?
Tidal volume (time frame: 15 min). 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 NCT01519258, 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 3 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.