Non Invasive Ventilation With NAVA vs ASV for AECOPD

NCT04414891 | Completed

• 1 other identifier: NAVA_ASV_AECOPD
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Neurally adjust ventilator assist is a new mode that may improve patient ventilator interactions, improve synchrony and contribute to improved outcomes. Likewise ASV is a mode principled on the closed loop system and is associated with reduction of work associated with breathing and improved outcomes. In this randomised, non-blinded trial, we study these two modes of NIV delivery in patients of AECOPD with hypothesis being that better synchrony with NAVA may translate to better clinical outcomes.

Conditions

Acute Exacerbation of COPD

Keywords

AECOPD; NIV; NAVA; ASV

Outcome Measures

Primary Outcomes (1)

• Rate of NIV failure

  NIV failure will be considered in case of • Endotracheal intubation

  From initiation of NIV to either intubation or re-initiation of NIV or successful weaning

Secondary Outcomes (8)

• 28-day mortality rate

  28 days

• 90-day mortality rate

  90 days

• Time to NIV failure

  28 days

• Time to successful weaning

  28 days

• Physician's ease of use of the mode on visual analogue scale

  Assessed every 8 hours until primary outcome

Study Arms (2)

NAVA arm

EXPERIMENTAL

Delivery of NIV-NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks. Subjects randomised to this arm will undergo placement of Edi catheter and will be initiated on NIV. Appropriate NAVA level will be selected based on the scalars corresponding to stable ventilation in pressure support mode. During NAVA, the NAVA level would be increased in multiples of 0.2 cm H2O/µV to attain favourable response (tidal volume 6-8mL/kg RR ≤25). Once the patient's clinical condition stabilises, and the Edi maximum starts declining or remains unchanged with stable tidal volumes, NAVA level will be decreased in steps of 0.2 cm H2O/μV every 2 hours. If response to new settings is not favourable earlier settings will be restored. If favourable response is attained the weaning is continued until peak pressure is \<12cm H20 and PEEP requirement is \<5cm H2O. NIV will be replaced by a venture mask to titrate SpO2 between 88-92%

Device: Non invasive ventilation

ASV arm

ACTIVE COMPARATOR

Patients randomised to the ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland). The patients will be ventilated with an initial setting of 100%-minute volume (MV%). Increments of 10% will be made every 15 minutes to achieve clinical response (relief of dyspnea, RR\<30, and tidal volume 6-8mL/kg). The expiratory trigger sensitivity will be set at 35% and adjusted accordingly. PEEP will be commenced at 3-4 cm H2O and increased by 1 cm of H2O to achieve SpO2 between 89-92% and maximum PEEP of 10 cm of H2O. Weaning would be performed by reducing the MV% gradually in decrements of 10%/hour to a MV% of 60% after the peak inspiratory pressure decreases to \<8 cm of H2O, and the respiratory rate is \< 28 breaths per minute and patient is able to maintain SpO2 \> 90% at FiO2\< 30%. Once the patient is comfortable on these settings, NIV will be replaced with oxygen supplementation using a venturi mask to maintain SpO2 between 89 and 92%.

Device: Non invasive ventilation

Interventions

Non invasive ventilation DEVICE

Non invasive ventilation will be delivered using an oro-facial interface in both arms. NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks. ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).

Also known as: NIV

ASV arm; NAVA arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with any one of the following criteria will be excluded from the current study:
• Non-COPD acute hyper-capneic respiratory failure
• Hypotension (systolic blood pressure \<90 mmHg)
• Severe impairment of consciousness (Glasgow coma scale score \<8)
• Inability to clear respiratory secretions
• 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)
• Unwillingness to undergo placement of nasogastric catheter
• Known phrenic nerve lesions
• Suspected diaphragmatic weakness
• Patient already on home NIV therapy for chronic respiratory failure
• Failure to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Respiratory Intensive Care Unit, PGIMER

Chandigarh, 160012, India

Location

Related Publications (6)

• Sehgal IS, Kalpakam H, Dhooria S, Aggarwal AN, Prasad KT, Agarwal R. A Randomized Controlled Trial of Noninvasive Ventilation with Pressure Support Ventilation and Adaptive Support Ventilation in Acute Exacerbation of COPD: A Feasibility Study. COPD. 2019 Apr;16(2):168-173. doi: 10.1080/15412555.2019.1620716. Epub 2019 Jun 4.

  PMID: 31161812 BACKGROUND

• Chen C, Wen T, Liao W. Neurally adjusted ventilatory assist versus pressure support ventilation in patient-ventilator interaction and clinical outcomes: a meta-analysis of clinical trials. Ann Transl Med. 2019 Aug;7(16):382. doi: 10.21037/atm.2019.07.60.

  PMID: 31555696 BACKGROUND

• Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22.

  PMID: 31641071 BACKGROUND

• Sehgal IS, Dhooria S, Aggarwal AN, Behera D, Agarwal R. Asynchrony index in pressure support ventilation (PSV) versus neurally adjusted ventilator assist (NAVA) during non-invasive ventilation (NIV) for respiratory failure: systematic review and meta-analysis. Intensive Care Med. 2016 Nov;42(11):1813-1815. doi: 10.1007/s00134-016-4508-z. Epub 2016 Aug 25. No abstract available.

  PMID: 27562243 BACKGROUND

• Wang DQ, Luo J, Xiong XH, Zhu LH, Zhang WW. [Effect of non-invasive NAVA on the patients with acute exacerbation of chronic obstructive pulmonary disease]. Zhonghua Yi Xue Za Zhi. 2016 Nov 15;96(42):3375-3378. doi: 10.3760/cma.j.issn.0376-2491.2016.42.004. Chinese.

  PMID: 27866528 BACKGROUND

• Chhabria BA, Prasad KT, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Gandra RR, Sehgal IS. A randomized controlled trial comparing non-invasive ventilation delivered using neurally adjusted ventilator assist (NAVA) or adaptive support ventilation (ASV) in patients with acute exacerbation of chronic obstructive pulmonary disease. J Crit Care. 2023 Jun;75:154250. doi: 10.1016/j.jcrc.2022.154250. Epub 2023 Jan 19.

  PMID: 36680884 DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Inderpaul Singh Sehgal, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Consecutive patients enrolled would be randomized to either the NAVA arm or ASV arm. NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) ASV NIV ASV will be administered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland)

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)