NIV - NAVA vs NIV - PS for COPD Exacerbation (NAVA-NICE)

February 9, 2018 updated by: Dr. Vijay Hadda, All India Institute of Medical Sciences, New Delhi

Non-invasive Ventilation (NIV) - Neurally Adjusted Ventilatory Assist (NAVA) vs NIV for Acute Hypercapneic Respiratory Failure in COPD: A Randomized Controlled Trial

Number of Patients:

Total no. of patients = 40 patients NIV-PSV group (Group A) = 20 NIV-NAVA group (Group B) = 20

Inclusion criteria

a) Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure (pH < 7.35 and PaCO2 >45 mmHg) requiring noninvasive ventilation and with no indication for invasive mechanical ventilation.

Exclusion criteria

  1. Patient with any contra-indication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, esophageal varices)
  2. Patient with any contraindication of noninvasive ventilation (such as hemodynamic instability, active gastrointestinal bleed etc)
  3. Patients with a known neuromuscular, central or peripheral nervous system disorder.
  4. Patient not willing to give consent.

Control(s): Patients receiving pressure support ventilation (NIV-PSV) will act as control

Study design: Randomized interventional study

Dosages of drug: None

Duration of treatment: Till patient improves or requires invasive ventilation.

Brief Methodology Patients of COPD with acute exacerbation will be randomized into two groups (group A and group B) to receive NIV-PSV or NIV-NAVA respectively. A special naso-gastric catheter (EAdi-catheter) will be placed in all patients. In each mode, NIV will be applied using a non-vented oro-nasal mask that will be fitted enough to avoid air leaks. Patients in Group A will receive NIV-PS and Group B will receive ventilation via NIV-NAVA. Pressure support and PEEP levels will be set by the treating physician to achieve a tidal volume (Vt) of 6 to 8 mL/kg of ideal body weight. NAVA level will be adjusted to match peak pressures of NIV-PSV using manufacturer-supplied software. After stabilization, a 30-min period of each NIV trial will be recorded and manually analyzed offline. Subsequent readings will be taken at 2, 6 and at 24 hours and then at 6 hourly interval from day 2 onwards. In each trial, patient-ventilator asynchronies (ineffective efforts, auto triggering, premature cycling, delayed cycling, and double triggering) will be determined on EAdi, airway pressure, and flow signal. The number of each type of asynchrony, defined as the number of events per minute, will be determined for each recording period. The asynchrony index (AI), in percentage, will be calculated as described previously, and an AI >10% will be considered severe asynchrony. Patient comfort level after each mode of ventilation will be assessed by using visual analogue scale. Various clinical, ventilatory and arterial blood gas parameters will be recorded.

Statistical analysis Data will be expressed as mean ± standard deviation (SD), or percentage. Differences in continuous variables between the two groups will be compared using student's t test (or Mann-Whitney U test); while differences in categorical data will be compared using the chi- square test (or Fisher's exact test). A p value of less than 0.05 will be considered statistically significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110029
        • AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of Chronic obstructive pulmonary disease with acute hypercapnic respiratory failure requiring noninvasive ventilation and with no indication for invasive mechanical ventilation will be included in the study.

Exclusion Criteria:

  • Patient with any contraindication for insertion of nasogastric tube (like recent gastrointestinal bleeding in previous 30 days, Esophageal varices)
  • Patient with any established contraindication of noninvasive ventilation. (Like Hemodynamic instability, active GI bleed etc)
  • Patients with a known neuromuscular, Central or peripheral nervous system disorder.
  • Patient not willing to give consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurally adjusted ventilator assist
Neurally adjusted ventilator assist (NAVA) during NIV for exacerbation of COPD.
Device: Neurally Adjusted Ventilator Assist
NAVA during Non-invasive ventilation
Other Names:
  • NAVA
Active Comparator: Pressure support ventilation
Pressure support ventilation (PSV) during NIV for exacerbation of COPD.
Device: Pressure support ventilation
PS during Non-invasive ventilation
Other Names:
  • PSV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the number of patient ventilator asynchrony
Time Frame: Entire period of ventilatory support, an average of 5 days
To assess the difference of number of patient ventilator asynchrony
Entire period of ventilatory support, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in rate of NIV failure
Time Frame: Entire hospital stay, an average of 7 days
To assess the difference of rate of NIV failure
Entire hospital stay, an average of 7 days
Difference in total duration of ventilatory support
Time Frame: Entire hospital stay, an average of 7 days
To assess the difference in total duration of ventilatory support
Entire hospital stay, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Vijay Hadda, MD, AIIMS, New Delhi, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECPG/360/29.06.2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will share, if required

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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