Early Non-invasive Ventilation Outside the Intensive Care Unit

Phase 4

Completed

• Conditions: Early Acute Respiratory Failure
• Interventions: Procedure: Non-invasive ventilation; Other: Standard care

• Registration Number: NCT01572337
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-16
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-06
• Primary Completion: 2023-08-17
• Study Completion: 2024-07-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV	Non-invasive ventilation	Non-invasive ventilation
Best available treatment	Standard care	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Ospedale Cesare Arrigo; 🇮🇹 Alessandria, Piemonte, Italy

University of Thessaly; 🇬🇷 Larissa, Greece

Ospedale di Novara; 🇮🇹 Novara, Piemonte, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Asl 3 Genovese; 🇮🇹 Genova, Italy

Ospedale Civile di Asti; 🇮🇹 Asti, Italy

Ospedali Galliera; 🇮🇹 Genova, Italy

Grande Ospedale Metropolitano; 🇮🇹 Reggio Calabria, Italy

AOU Pisana; 🇮🇹 Pisa, Italy

Policlinico A. Gemelli; 🇮🇹 Roma, Italy

Azienda Ospedaliera San Giovanni Battista Molinette; 🇮🇹 Torino, Italy

Astana Medical University; 🇰🇿 Kazakhstan, Kazakhstan

Aurelia Hospital; 🇮🇹 Roma, Italy

Ospedale San Raffaele di Milano; 🇮🇹 Milan, MI, Italy