NIV - NAVA vs NIV - PS for COPD Exacerbation
Condition: COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

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.
    


Intervention name(s): Neurally Adjusted Ventilator Assist; Pressure support ventilation
Intervention type(s): Device; Device
Intervention description(s): NAVA during Non-invasive ventilation; PS during Non-invasive ventilation
Other intervention name(s): NAVA; PSV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; Non-invasive ventilation; NAVA