Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)

NCT03271671 | Completed DMC

• 1 other identifier: TRB2447/1/7/17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure was 1,917,910 in the year 2009.(1) The incidence of ARF requiring hospitalization was 137.1 per 100,000 population.(2) In ARF due to chronic obstructive pulmonary disease (COPD) and cardiogenic pulmonary edema, non-invasive ventilation (NIV) has been shown to be beneficial. NIV also has several advantages over invasive mechanical ventilation. These include, avoidance of endotracheal intubation and its attendant complications like airway injury, nosocomial infections, and possibly shorter duration of intensive care unit (ICU) stay.(3, 4) The success of NIV depends on several factors like the etiology of the respiratory failure, careful monitoring by the treating physician, and also adequate cooperation of patient. Better synchrony of the patient's spontaneous breaths with the ventilator-delivered breaths may lead to better patient cooperation and thereby, better clinical outcomes. Patient-ventilator asynchrony (PVA) leads to dyspnea, increased work of breathing, and prolonged duration of mechanical ventilation.(5) Pressure support ventilation (PSV) is one of the commonest mode used during NIV. In a prospective multicenter observational study, severe asynchrony (defined as an asynchrony index of \>10 %) was seen in 43% of patients of patients with ARF ventilated by NIV with the conventional PSV mode.(6) Neurally adjusted ventilator assist (NAVA) is new mode of ventilation which utilizes the electrical activity of the diaphragm to deliver the breath.(7) During NAVA, breath is delivered when the patient's diaphragm starts contracting. Further, the amount of pressure support given during the breath is proportional to the strength of the electrical signal from the diaphragm. Finally, NAVA also terminates the breath when the electrical activity of the diaphragm wanes. NAVA has been shown to avoid over-assistance, decrease intrinsic positive end-expiratory pressure (PEEP), and minimize wasted efforts.(8) Hence, NAVA may play a major role in improving patient-ventilator synchrony. In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.

Conditions

Respiratory Failure

Keywords

neurally adjusted ventilator assist; Pressure support ventilation; non invasive ventilation; niv

Outcome Measures

Primary Outcomes (2)

• Rates of NIV failures

  NIV will be deemed to have failed if the patient gets intubated or is reinitiated on NIV within 48 hours of discontinuation of NIV

  28 days

• 28-day mortality

  28-day mortality including ICU and hospital deaths will be assessed

  28 days

Secondary Outcomes (6)

• Time to successful weaning

  28 days

• Time to NIV failure

  28 days

• Total duration of mechanical ventilation (both non-invasive and invasive)

  28 days

• Length of ICU and hospital stay

  28 days

• Patient's level of comfort during NIV using VAS

  28 days

Study Arms (2)

PSV

ACTIVE COMPARATOR

Pressure support ventilation

Other: PSV during Non invasive ventilation

NAVA

EXPERIMENTAL

Neurally adjusted ventilator assist

Other: NAVA during Non invasive ventilation

Interventions

NAVA during Non invasive ventilation OTHER

NIV during respiratory failure

NAVA

PSV during Non invasive ventilation OTHER

PSV during respiratory failure

PSV

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Respiratory rate \>30 per minute
• Arterial blood gas analysis showing a PaCO2 \>45 mmHg and pH \<7.35
• PaO2/FiO2 ratio \< 300
• Use of accessory muscles of respiration or paradoxical respiration

You may not qualify if:

• Age \<18 years or \>75 years
• Pregnancy
• PaO2/FiO2 ratio ≤100
• Hypotension (systolic blood pressure \<90 mmHg)
• Severe impairment of consciousness (Glasgow coma scale score \<8)
• Inability to clear respiratory secretions (Airway care score \[ACS\] ≥12)(27)
• Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality)
• Subjects who have an artificial airway like tracheostomy tube or T-tube
• Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
• More than two organ failures
• Unwillingness to undergo placement of nasogastric catheter
• Known phrenic nerve lesions
• Suspected diaphragmatic weakness
• Patient already on home NIV therapy for chronic respiratory failure
• Application of NIV for more than one hour for the current illness

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Respiratory ICU, Post Graduate Institue of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (7)

• Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Steingrub JS, Lagu T, Lindenauer PK. Epidemiology and outcomes of acute respiratory failure in the United States, 2001 to 2009: a national survey. J Hosp Med. 2013 Feb;8(2):76-82. doi: 10.1002/jhm.2004. Epub 2013 Jan 18.

  PMID: 23335231 BACKGROUND

• Behrendt CE. Acute respiratory failure in the United States: incidence and 31-day survival. Chest. 2000 Oct;118(4):1100-5. doi: 10.1378/chest.118.4.1100.

  PMID: 11035684 BACKGROUND

• Peter JV, Moran JL, Phillips-Hughes J, Warn D. Noninvasive ventilation in acute respiratory failure--a meta-analysis update. Crit Care Med. 2002 Mar;30(3):555-62. doi: 10.1097/00003246-200203000-00010.

  PMID: 11990914 BACKGROUND

• Girou E, Schortgen F, Delclaux C, Brun-Buisson C, Blot F, Lefort Y, Lemaire F, Brochard L. Association of noninvasive ventilation with nosocomial infections and survival in critically ill patients. JAMA. 2000 Nov 8;284(18):2361-7. doi: 10.1001/jama.284.18.2361.

  PMID: 11066187 BACKGROUND

• Georgopoulos D, Prinianakis G, Kondili E. Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies. Intensive Care Med. 2006 Jan;32(1):34-47. doi: 10.1007/s00134-005-2828-5. Epub 2005 Nov 9.

  PMID: 16283171 BACKGROUND

• 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 BACKGROUND

• Prasad KT, Gandra RR, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Sehgal IS. Comparing Noninvasive Ventilation Delivered Using Neurally-Adjusted Ventilatory Assist or Pressure Support in Acute Respiratory Failure. Respir Care. 2021 Feb;66(2):213-220. doi: 10.4187/respcare.07952. Epub 2020 Sep 1.

  PMID: 32873750 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Inderpaul S Sehgal, MD,DM

  PGIMER,Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pulmonary Medicine

Model Details: Randomized controlled trial comparing two modes of non invasive ventilation

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 5, 2017
• Study Start: October 1, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 31, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

IN (1)