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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01572337
Recruitment Status : Recruiting
First Posted : April 6, 2012
Last Update Posted : September 28, 2018
Information provided by (Responsible Party):
Giovanni Landoni, 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.

Condition or disease Intervention/treatment Phase
Early Acute Respiratory Failure Procedure: Non-invasive ventilation Other: Standard care Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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.
Study Start Date : April 2012
Estimated Primary Completion Date : April 2020
Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: NIV
Non-invasive ventilation
Procedure: Non-invasive ventilation
Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure
Other Names:
  • Noninvasive ventilation
  • NIV

Best available treatment Other: Standard care

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572337

Contact: Giovanni Landoni

Ospedale San Raffaele di Milano Recruiting
Milan, MI, Italy, 20132
Contact: Giovanni Landoni   
Ospedale Civile di Asti Recruiting
Asti, Italy
Contact: Agostino Roasio, MD         
Spedali Civili Recruiting
Brescia, Italy
Contact: Matteo Filippini, MD         
Asl 3 Genovese Recruiting
Genova, Italy
Contact: Lorenzo Ferrara, MD         
Ospedali Galliera Recruiting
Genova, Italy
Contact: Francesco Corradi, MD         
Aurelia Hospital Recruiting
Roma, Italy
Contact: Virginia Cotticelli, MD         
Policlinico A. Gemelli Not yet recruiting
Roma, Italy
Contact: Massimo Antonelli         
Azienda Ospedaliera San Giovanni Battista Molinette Not yet recruiting
Torino, Italy
Contact: Marco Ranieri         
Sponsors and Collaborators
Università Vita-Salute San Raffaele

Responsible Party: Giovanni Landoni, Head of Research, Department of Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele Identifier: NCT01572337     History of Changes
Other Study ID Numbers: VP/96/ER/mm
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by Giovanni Landoni, Università Vita-Salute San Raffaele:
acute respiratory failure
non-invasive ventilation
hospital ward

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases