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New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation

Primary Purpose

Acute Respiratory Failure, Mechanical Ventilation Complication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PSP
NAVA
PSN
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Failure focused on measuring non-invasive ventilation, Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, patient-ventilator interaction, ventilator performance, asynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The investigators considered eligible:

  • any patient ≥18 years admitted in ICU undergoing invasive mechanical ventilation for at least 48 hours with a Glasgow Coma Scale (GCS) of 11 (i.e.; spontaneous eyes opening, obeys to command, no verbal response because of the endotracheal tube in place),
  • no infusion of midazolam and propofol in the previous 24 and 4 hours, respectively
  • ready for extubation with indication, prior to extubation, to receive prophylactic NIV to prevent post-extubation respiratory failure.

Patients were excluded in case of

  • need for analgesic or sedative drugs,
  • recent cervical spine injury,
  • obstructive sleep apnoea syndrome,
  • pregnancy,
  • contraindications to placement of a nasal-gastric feeding tube,
  • inclusion in other research protocol
  • lack of consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    PSP ventilation

    NAVA ventilation

    PSN ventilation

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    Rate of ventilator cycling (RRmec)

    Secondary Outcome Measures

    respiratory drive (Peak of Electrical Activity of the Diaphragm)
    arterial blood gases
    Pressure-time product (PTP) of the first 200 ms from the onset of the ventilator pressurization (PTP200)
    patient's comfort through an 11-point Numeric Rating Scale (NRS)
    inspiratory trigger delay (DelayTR-insp), as the time lag between the onset of neural inspiration and ventilator support

    Full Information

    First Posted
    January 12, 2017
    Last Updated
    February 1, 2017
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03041402
    Brief Title
    New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation
    Official Title
    New Setting of Neurally Adjusted Ventilatory Assist During Postextubation Prophylactic Noninvasive Ventilation Through a Mask: a Physiologic Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southeast University, China

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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%).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Failure, Mechanical Ventilation Complication
    Keywords
    non-invasive ventilation, Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, patient-ventilator interaction, ventilator performance, asynchrony

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PSP ventilation
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    NAVA ventilation
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    PSN ventilation
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    PSP
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    NAVA
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    PSN
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Rate of ventilator cycling (RRmec)
    Time Frame
    30 minutes within the trial
    Secondary Outcome Measure Information:
    Title
    respiratory drive (Peak of Electrical Activity of the Diaphragm)
    Time Frame
    30 minutes within the trial
    Title
    arterial blood gases
    Time Frame
    30 minutes within the trial
    Title
    Pressure-time product (PTP) of the first 200 ms from the onset of the ventilator pressurization (PTP200)
    Time Frame
    30 minutes within the trial
    Title
    patient's comfort through an 11-point Numeric Rating Scale (NRS)
    Time Frame
    30 minutes within the trial
    Title
    inspiratory trigger delay (DelayTR-insp), as the time lag between the onset of neural inspiration and ventilator support
    Time Frame
    30 minutes within the trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    The investigators considered eligible: any patient ≥18 years admitted in ICU undergoing invasive mechanical ventilation for at least 48 hours with a Glasgow Coma Scale (GCS) of 11 (i.e.; spontaneous eyes opening, obeys to command, no verbal response because of the endotracheal tube in place), no infusion of midazolam and propofol in the previous 24 and 4 hours, respectively ready for extubation with indication, prior to extubation, to receive prophylactic NIV to prevent post-extubation respiratory failure. Patients were excluded in case of need for analgesic or sedative drugs, recent cervical spine injury, obstructive sleep apnoea syndrome, pregnancy, contraindications to placement of a nasal-gastric feeding tube, inclusion in other research protocol lack of consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pan Chun, MD
    Organizational Affiliation
    Department of Critical Care Medicine, Zhongda Hospital, Southeast University, School of Medicine, 87 Dingjiaqiao Street, Nanjing 210009, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27649505
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25486574
    Citation
    Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.
    Results Reference
    result
    PubMed Identifier
    19183949
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22610179
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22661448
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    22885649
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28683763
    Citation
    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.
    Results Reference
    derived

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    New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation

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