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Acute Respiratory FailureNCT03041402

New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation

A study testing PSP, NAVA and PSN in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Southeast University, China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PSP, NAVA and PSN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Mar 2013to Sep 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

  • lack of consent.

Who cannot join

None listed.

About this study

Official title: New Setting of Neurally Adjusted Ventilatory Assist During Postextubation Prophylactic Noninvasive Ventilation Through a Mask: a Physiologic Study

Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance, improves patient-ventilator interaction. A specific setting to generate neurally controlled Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony.

Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of asynchrony, as assessed by the Asynchrony Index (AI%).

Read the detailed description

Non Invasive Ventilation (NIV) is increasingly used for treatment of Acute Respiratory Failure (ARF) and is commonly applied through an oral-nasal mask by means of pneumatically triggered and cycled-off Pressure Support (PSP). Although better tolerated than invasive mechanical ventilation, NIV is characterized by drawbacks such as poor patient-ventilator interaction and discomfort, which are major determinants of NIV failure.

In particular, the pneumatic signals, i.e., flow, volume and airway pressure (Paw), are leak sensitive and frequently cause patient-ventilator asynchrony. The only mode that does not use pneumatic signals to trigger and drive the ventilator is Neurally Adjusted Ventilator Assist (NAVA). In fact, with NAVA the ventilator assistance is under control of diaphragm electrical activity (EAdi), as assessed through an esophageal catheter. As opposed to PSP, NAVA has been repeatedly shown to improve patient-ventilator interaction and reduce asynchronies, both during invasive ventilation and NIV. However, NAVA is characterized by a lower rate of pressurization than PSP.

Very recently, a specific NIV setting to generate a neurally, i.e., EAdi, controlled Pressure Support (PSN) has been proposed and applied during both invasive ventilation and NIV delivered via helmet. PSN consists in increasing the user-controlled gain factor (NAVA level) at maximum, while restraining inspiratory Paw by adjusting on the ventilator the upper pressure limit.

During NIV delivered through helmets, PSN has been shown, compared to both PSP and NAVA, to result in better pressurization and triggering performance, which improve patient's comfort while reducing EAdi, without affecting respiratory rate and arterial blood gases (ABGs). Due to the different characteristics of helmets and masks, it is unclear whether these advantages could be extended to NIV delivered by mask. The investigators therefore designed this physiological study aimed at comparing PSN with PSP and NAVA, with respect to breathing pattern, respiratory drive, ABGs, pressurization and triggering performance, patient's comfort and patient-ventilator synchrony.

After patient enrollment, a nasal-gastric feeding tube able to detect EAdi (EAdi catheter, Maquet Critical Care, Solna, Sweden) was placed and the correct positioning ascertained. The study was performed using a Servo-I ventilator (Maquet Critical Care, Solna, Sweden) equipped with a NIV software for air-leaks. The oral-nasal mask was individually selected for each patients based on the anthropometric characteristics and in order to minimize air leaks and optimize patient tolerance, among three different models, FreeMotion RT041 Non Vented Full Face Mask (Fisher and Paykel, Auckland, New Zealand), Ultra Mirage FFM-NV (ResMed, San Diego, CA, USA) and PerforMax Face Mask (Philips Respironics, Murrysville, PA, USA).

All patients underwent three 30-minute trials in random order: 1) PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow (PIF); 2) NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O; 3) PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP. During both NAVA and PSN the trigger sensitivity was set at 0.5 mcV while, the default cycling-off is 70% EAdipeak, as fixed by the manufacturer. PEEP was set by the attending physicians in a range between 5 and 10 cmH2O, and left unmodified throughout the whole study period. The inspiratory oxygen fraction (FiO2) was regulated to obtain peripheral oxygen saturation (SpO2) between 94% and 96%, before starting the protocol, and kept unmodified throughout the study period.

The three modes of ventilation were applied according to a computer-generated random sequence using sealed, opaque numbered envelops. The envelopes were kept in the head of nurses' office in both institutions. The envelope was opened by the nurse in charge of the patient, and the sequence of modes to be applied communicated to the investigators.

Predefined criteria for protocol interruption were: 1) need for emergency re-intubation; 2) SpO2 <90%, 3) acute respiratory acidosis, as defined by PaCO2 >50 mmHg and pH <7.30; 3) inability to expectorate secretions; 4) hemodynamic instability (i.e.; need for continuous infusion of dopamine or dobutamine >5 µg∙kg-1∙min-1, norepinephrine >0.1 µg∙kg-1∙min-1 or epinephrine or vasopressin at any dosage to maintain mean arterial blood pressure >60 mmHg); 5) life-threatening arrhythmias or electrocardiographic signs of ischemia; or 6) loss of 2 or more points of GCS.

Being tested
PSP, NAVA, PSN
Keywords
non-invasive ventilation, Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, patient-ventilator interaction, ventilator performance, asynchrony

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSPOther

    PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow

  • NAVAOther

    NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O

  • PSNOther

    PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP

Study groups in NCT03041402
Study groupRoleWhat they receive
PSP ventilationActive comparatorPSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow
Receives: Other: PSP; Other: NAVA; Other: PSN
NAVA ventilationActive comparatorNAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O
Receives: Other: PSP; Other: NAVA; Other: PSN
PSN ventilationExperimentalPSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP
Receives: Other: PSP; Other: NAVA; Other: PSN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ventilator cycling (RRmec)

    Measured: 30 minutes within the trial

Secondary outcomes (5)
  1. respiratory drive (Peak of Electrical Activity of the Diaphragm)

    Measured: 30 minutes within the trial

  2. arterial blood gases

    Measured: 30 minutes within the trial

  3. Pressure-time product (PTP) of the first 200 ms from the onset of the ventilator pressurization (PTP200)

    Measured: 30 minutes within the trial

  4. patient's comfort through an 11-point Numeric Rating Scale (NRS)

    Measured: 30 minutes within the trial

  5. inspiratory trigger delay (DelayTR-insp), as the time lag between the onset of neural inspiration and ventilator support

    Measured: 30 minutes within the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2017 (estimated)
  2. Study startMar 2013
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041402
Sponsor's protocol ID
Neural PSV during mask NIV
Status last verified
Jan 2017
First submitted
12 Jan 2017
Last updated
2 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cammarota G, Longhini F, Perucca R, Ronco C, Colombo D, Messina A, Vaschetto R, Navalesi P. New Setting of Neurally Adjusted Ventilatory Assist during Noninvasive Ventilation through a Helmet. Anesthesiology. 2016 Dec;125(6):1181-1189. doi: 10.1097/ALN.0000000000001354.

    PubMed 27649505
  • Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.

    PubMed 25486574
  • Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.

    PubMed 19183949
  • Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.

    PubMed 22610179
  • Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.

    PubMed 22661448
  • Piquilloud L, Tassaux D, Bialais E, Lambermont B, Sottiaux T, Roeseler J, Laterre PF, Jolliet P, Revelly JP. Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator interaction during non-invasive ventilation delivered by face mask. Intensive Care Med. 2012 Oct;38(10):1624-31. doi: 10.1007/s00134-012-2626-9. Epub 2012 Aug 3.

    PubMed 22885649
  • Longhini F, Pan C, Xie J, Cammarota G, Bruni A, Garofalo E, Yang Y, Navalesi P, Qiu H. New setting of neurally adjusted ventilatory assist for noninvasive ventilation by facial mask: a physiologic study. Crit Care. 2017 Jul 7;21(1):170. doi: 10.1186/s13054-017-1761-7.

    PubMed 28683763

Questions about this trial

What is this clinical trial studying?

A study testing PSP, NAVA and PSN in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Southeast University, China.

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 1 inclusion and 0 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Rate of ventilator cycling (RRmec) (time frame: 30 minutes within the trial). 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 NCT03041402, which also lists 7 linked publications.

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 2 Feb 2017.

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