Early Non-invasive Ventilation Outside the Intensive Care Unit (NAVIGATE)

Università Vita-Salute San Raffaele

Status and phase

Completed

Phase 4

Conditions

Early Acute Respiratory Failure

Treatments

Other: Standard care

Procedure: Non-invasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01572337

VP/96/ER/mm

Details and patient eligibility

About

A large multicentre, randomized, controlled trial to demonstrate that non invasive ventilation given at an early stage of acute respiratory failure (ARF) outside the intensive care unit (ICU) can prevent the deterioration of ARF and the need for ICU when compared to the best available treatment usually performed in the non-ICU wards.

Enrollment

520 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent
Age >= 18 years
Admission in a non-intensive-care department
Radiological evidence of new pulmonary consolidation or atelectasis
Peripheral Oxygen saturation less than 92% while breathing room air or PaO2/FiO2 ratio less than 300 at blood gas analysis
Decompensated hypercapnia (pCO2 > 45 mmHg and pH < 7.35)
Clinical signs of respiratory distress (dyspnoea, utilization of accessory respiratory muscles, paradox movements of thoraco-abdominal wall) in air.

Exclusion criteria

Respiratory failure due to chronic obstructive pulmonary disease exacerbation, defined as PaCO2 > 45 and pH < 7.35 (in these patients NIV is considered to be the standard/first line treatment and we do not want to deny these patients the opportunity to receive this treatment because of randomization)
Severe, hypercapnic ARF defined as PaCO2 > 45 and pH < 7.30
Severe, hypoxic ARF defined as PaO2/FiO2 < 200
Need for immediate mechanical ventilation or ICU as judged by the ICU physician in charge
Extremely poor short term prognosis (imminent death with decision for palliative treatment only)
Invasive or non-invasive mechanical ventilation during the same hospitalization due to respiratory failure.
Clear contraindication to NIV treatment: respiratory arrest, failure to correct positioning of a face mask, hemodynamic instability due to hypotensive shock, ongoing myocardial ischemia, arrhythmia, massive bleeding from upper gastrointestinal tract, patient uncooperative and upset, inability to protect airways, alterations of deglutition, inability to clear secretion also with external aspiration, multiple organs dysfunction, recent surgery of airways or upper gastrointestinal tract, not-drained pneumothorax, bowel obstruction, active vomit.