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Completed

NCT Number: NCT01572337

Early Non-invasive Ventilation Outside the Intensive Care Unit

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Thessaly, Larissa, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive ventilation

Procedure

Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure

Other names: Noninvasive ventilation, NIV

Standard care

Other

Primary outcomes

  1. Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Reducing the Need for Intensive Care Unit in Hospitalized Patients With Early Respiratory Failure Using the Non-invasive Ventilation Technique. A Multicentre Randomized Study.

Acronym: NAVIGATE

Important dates

Study start
2012
Primary completion
2023
Study completion
2024
First posted
Apr 6, 2012
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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