New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation

NCT03041402 | Completed

• 1 other identifier: Neural PSV during mask NIV
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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%).

Conditions

Acute Respiratory Failure; Mechanical Ventilation Complication

Keywords

non-invasive ventilation; Pressure Support Ventilation; Neurally Adjusted Ventilatory Assist; patient-ventilator interaction; ventilator performance; asynchrony

Outcome Measures

Primary Outcomes (1)

• Rate of ventilator cycling (RRmec)

  30 minutes within the trial

Secondary Outcomes (5)

• respiratory drive (Peak of Electrical Activity of the Diaphragm)

  30 minutes within the trial

• arterial blood gases

  30 minutes within the trial

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

  30 minutes within the trial

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

  30 minutes within the trial

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

  30 minutes within the trial

Study Arms (3)

PSP ventilation

ACTIVE COMPARATOR

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

Other: PSP; Other: NAVA; Other: PSN

NAVA ventilation

ACTIVE COMPARATOR

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

Other: PSP; Other: NAVA; Other: PSN

PSN ventilation

EXPERIMENTAL

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

Other: PSP; Other: NAVA; Other: PSN

Interventions

PSP OTHER

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 ventilation; PSN ventilation; PSP ventilation

NAVA OTHER

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

NAVA ventilation; PSN ventilation; PSP ventilation

PSN OTHER

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

NAVA ventilation; PSN ventilation; PSP ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Southeast University, China: lead

Related Publications (7)

• 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.

  PMID: 27649505 RESULT

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

  PMID: 25486574 RESULT

• 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.

  PMID: 19183949 RESULT

• 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.

  PMID: 22610179 RESULT

• 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.

  PMID: 22661448 RESULT

• 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.

  PMID: 22885649 RESULT

• 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.

  PMID: 28683763 DERIVED

Study Officials

• Pan Chun, MD

  Department of Critical Care Medicine, Zhongda Hospital, Southeast University, School of Medicine, 87 Dingjiaqiao Street, Nanjing 210009, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: February 2, 2017
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share