Non Invasive Ventilation With NAVA vs ASV for AECOPD

Acute Exacerbation of COPD Clinical Trial

Official title:

A Randomized Controlled Trial of Non-invasive Ventilation With Adaptive Support Ventilation Versus Neurally Adjusted Ventilator Assist in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414891
• Other study ID #: NAVA_ASV_AECOPD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study hypothesis We hypothesize that NIV-NAVA would be superior to ASV in reducing the NIV failure rates in patients with AECOPD. In this study, we plan to compare the ASV with NAVA during NIV in patients with AECOPD.

Methods All consecutive patients meeting the inclusion criteria will be screened and assessed for eligibility. Informed consent will be sought and those enrolled would be randomized to to receive NIV using either the ASV or the NIV-NAVA mode. The NIV will be delivered using a oro-nasal mask with supplemental oxygen as needed.

Delivery of NAVA NAVA will be delivered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.

NAVA initiation would involve calibration of the Edi module, placement of the nava catheter nasogastrically, verification of position and selecting appropriate nava level on the basis of required pressure support. In case a favourable response is not obtained, NAVA level will beincreased by 0.2 cm/µV until favourable response is seen (tidal volume 6-8mL/kg, respiratory rate < 25/min)

Delivery of ASV ASV will be delivered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).The patients will be ventilated with an initial setting of 100%-minute volume and will be titrated in increments of 10% as per clinical parameters (respiratory rate, tidal volume).

Monitoring All the patients will be monitored every 15 minutes for respiratory rate, heart rate, blood pressure, Glasgow coma score, pulse oximetry, and signs of respiratory fatigue (paradox), fit of mask and any peri-mask leak. Arterial blood gas analysis will be done at initiation of NIV and then at 1 hour, 4 hours and 24 hours and then at least once a day till primary end point is met.

All the subjects will receive standard of care for acute exacerbation of COPD regardless of their allotted treatment arm.

Randomization Randomization will be done by a computer-generated sequence with blocks of 8 to receive non-invasive ventilation using either the ASV or NAVA. The order of randomisation will be sealed in an opaque envelope, and opened by the physician not directly involved in the study or analysis, at the time of recruitment of patient.

Statistical analysis Results will be presented in a descriptive fashion as mean ± standard deviation (SD), median (interquartile range) or number and percentage. The differences between means of continuous and categorical variables will be analysed using the Student-t-test and chi-square tests, respectively. For data that is not normally distributed the data will be analysed using non-parametric test (Mann-Whitney U).Trends in clinical (respiratory rate and mean arterial blood pressure), arterial blood gas parameters (pH, PaO2, PaCO2) and NIV parameters (peak inspiratory pressure, PEEP, tidal volume) will be analyzed using mixed model technique for repeated measures analysis of variance; the within-groups factor will be time (baseline, one, four and 24 hours), and the between-groups factor will be NIV success. A P value of <0.05 will indicate statistical significance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following: (a) an acute (<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation; (b) arterial blood gas analysis showing a PaCO2 >45 mm Hg with either pH between 7.10 and 7.35 or respiratory rate (fR) >30 breaths/minute; and, (c) exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Exclusion Criteria:

Patients with any one of the following criteria will be excluded from the current study:

1. Non-COPD acute hyper-capneic respiratory failure

2. Hypotension (systolic blood pressure <90 mmHg)

3. Severe impairment of consciousness (Glasgow coma scale score <8)

4. Inability to clear respiratory secretions

5. Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality

6. Subjects who have an artificial airway like tracheostomy tube or T-tube

7. Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)

8. Unwillingness to undergo placement of nasogastric catheter

9. Known phrenic nerve lesions

10. Suspected diaphragmatic weakness

11. Patient already on home NIV therapy for chronic respiratory failure

12. Failure to provide informed consent

Related Conditions & MeSH terms

• Acute Exacerbation of COPD

Intervention

Device:
• Non invasive ventilation
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).

Locations

Country	Name	City	State
India	Respiratory Intensive Care Unit, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (5)

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. — View Citation

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. Epub 2016 Aug 25. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28-day mortality rate	28-day mortality including ICU and hospital deaths will be assessed	28 days
Secondary	90-day mortality rate	90-day mortality including deaths after discharge	90 days
Secondary	Time to NIV failure	From initiation of NIV to either intubation or re-initiation of NIV	28 days
Secondary	Time to successful weaning	Time to successful weaning will be defined as the duration between initiation of NIV and successful weaning from NIV	28 days
Secondary	Physician's ease of use of the mode on visual analogue scale	Ease of use will be recorded on a scale of 100 mm, with 0 being very easy and 100 very difficult	Assessed every 8 hours until primary outcome
Secondary	Patient assessed level of comfort using visual analogue scale	Level of comfort will be assessed on a scale of 100 mm, 0 being very comfortable and 100 very uncomfortable	28 days
Secondary	Average number of manipulations	Assessed daily for 5 days or until primary outcome whichever occurs first	28 days
Secondary	Asynchrony index	Assessed daily until primary outcome or 5 day period, whichever occurs first	28 days