NCT02912689

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

September 4, 2016

Last Update Submit

February 9, 2018

Conditions

COPD Exacerbation

Keywords

COPDNon-invasive ventilationNAVA

Outcome Measures

Primary Outcomes (1)

  • Difference in the number of patient ventilator asynchrony

    To assess the difference of number of patient ventilator asynchrony

    Entire period of ventilatory support, an average of 5 days

Secondary Outcomes (2)

  • Difference in rate of NIV failure

    Entire hospital stay, an average of 7 days

  • Difference in total duration of ventilatory support

    Entire hospital stay, an average of 7 days

Study Arms (2)

Neurally adjusted ventilator assist

EXPERIMENTAL

Neurally adjusted ventilator assist (NAVA) during NIV for exacerbation of COPD.

Device: Neurally Adjusted Ventilator Assist

Pressure support ventilation

ACTIVE COMPARATOR

Pressure support ventilation (PSV) during NIV for exacerbation of COPD.

Device: Pressure support ventilation

Interventions

Neurally Adjusted Ventilator AssistDEVICE

NAVA during Non-invasive ventilation

Also known as: NAVA
Neurally adjusted ventilator assist
Pressure support ventilationDEVICE

PS during Non-invasive ventilation

Also known as: PSV
Pressure support ventilation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIIMS

New Delhi, 110029, India

Location

Related Publications (1)

  • 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: 31641071DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vijay Hadda, MD

    AIIMS, New Delhi, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 23, 2016

Study Start

September 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Will share, if required

Locations

IN(1)