Status:

COMPLETED

Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)

Lead Sponsor:

Post Graduate Institute of Medical Education and Research, Chandigarh

Conditions:

Respiratory Failure

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

Acute respiratory failure (ARF) is a life-threatening emergency which occurs due to impaired gas exchange. In the US, the number of hospitalisations owing to acute respiratory failure was 1,917,910 in...

Detailed Description

NIV is mode of ventilation wherein positive pressure ventilation is delivered by non-invasive interface like nasal mask, face mask, nasal plugs or helmet avoiding invasive interface by endotracheal in...

Eligibility Criteria

Inclusion

  • Respiratory rate \>30 per minute
  • Arterial blood gas analysis showing a PaCO2 \>45 mmHg and pH \<7.35
  • PaO2/FiO2 ratio \< 300
  • Use of accessory muscles of respiration or paradoxical respiration

Exclusion

  • Age \<18 years or \>75 years
  • Pregnancy
  • PaO2/FiO2 ratio ≤100
  • Hypotension (systolic blood pressure \<90 mmHg)
  • Severe impairment of consciousness (Glasgow coma scale score \<8)
  • Inability to clear respiratory secretions (Airway care score \[ACS\] ≥12)(27)
  • Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality)
  • Subjects who have an artificial airway like tracheostomy tube or T-tube
  • Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
  • More than two organ failures
  • Unwillingness to undergo placement of nasogastric catheter
  • Known phrenic nerve lesions
  • Suspected diaphragmatic weakness
  • Patient already on home NIV therapy for chronic respiratory failure
  • Application of NIV for more than one hour for the current illness
  • Failure to provide informed consent

Key Trial Info

Start Date :

October 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2019

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT03271671

Start Date

October 1 2017

End Date

March 31 2019

Last Update

April 10 2019

Active Locations (1)

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1

Respiratory ICU, Post Graduate Institue of Medical Education and Research

Chandigarh, India, 160012