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

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ClinicalTrials.gov Identifier: NCT02912689
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Vijay Hadda, All India Institute of Medical Sciences, New Delhi

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. 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.


Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: Neurally Adjusted Ventilator Assist Device: Pressure support ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation (NIV) - Neurally Adjusted Ventilatory Assist (NAVA) vs NIV for Acute Hypercapneic Respiratory Failure in COPD: A Randomized Controlled Trial
Study Start Date : September 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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 Name: 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 Name: PSV




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912689


Locations
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India
AIIMS
New Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Vijay Hadda, MD AIIMS, New Delhi, INDIA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Vijay Hadda, Assistant Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02912689    
Other Study ID Numbers: IECPG/360/29.06.2016
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will share, if required
Keywords provided by Dr. Vijay Hadda, All India Institute of Medical Sciences, New Delhi:
COPD
Non-invasive ventilation
NAVA
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases