Early Acute Respiratory Failure Clinical Trial
— NAVIGATEOfficial 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.
| Verified date | January 2024 |
| Source | Università Vita-Salute San Raffaele |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 520 |
| Est. completion date | July 18, 2024 |
| Est. primary completion date | August 17, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University of Thessaly | Larissa | |
| Italy | Ospedale Cesare Arrigo | Alessandria | Piemonte |
| Italy | Ospedale Civile di Asti | Asti | |
| Italy | Spedali Civili | Brescia | |
| Italy | Asl 3 Genovese | Genova | |
| Italy | Ospedali Galliera | Genova | |
| Italy | Ospedale San Raffaele di Milano | Milan | MI |
| Italy | Ospedale di Novara | Novara | Piemonte |
| Italy | AOU Pisana | Pisa | |
| Italy | Grande Ospedale Metropolitano | Reggio Calabria | |
| Italy | Aurelia Hospital | Roma | |
| Italy | Policlinico A. Gemelli | Roma | |
| Italy | Azienda Ospedaliera San Giovanni Battista Molinette | Torino | |
| Kazakhstan | Astana Medical University | Kazakhstan |
| Lead Sponsor | Collaborator |
|---|---|
| Università Vita-Salute San Raffaele |
Greece, Italy, Kazakhstan,
Cabrini L, Nobile L, Plumari VP, Landoni G, Borghi G, Mucchetti M, Zangrillo A. Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review. Br J Anaesth. 2014 Apr;112(4):638-47. doi: 10.1093/bja/aet465. Epub 2014 Jan 19. — View Citation
Cabrini L, Plumari VP, Nobile L, Olper L, Pasin L, Bocchino S, Landoni G, Beretta L, Zangrillo A. Non-invasive ventilation in cardiac surgery: a concise review. Heart Lung Vessel. 2013;5(3):137-41. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |