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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01572337
First received: March 16, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Early Acute Respiratory Failure
Procedure: Non-invasive ventilation
Other: Standard care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 520
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572337

Contacts
Contact: Giovanni Landoni landoni.giovanni@hsr.it

Locations
Italy
Ospedale San Raffaele di Milano Recruiting
Milan, MI, Italy, 20132
Contact: Giovanni Landoni       landoni.giovanni@hsr.it   
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
  More Information

Publications:
Responsible Party: Giovanni Landoni, Head of Research, Department of Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01572337     History of Changes
Other Study ID Numbers: VP/96/ER/mm
Study First Received: March 16, 2012
Last Updated: April 2, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
NIV
acute respiratory failure
hypoxia
hypercapnia
non-invasive ventilation
hospital ward

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

ClinicalTrials.gov processed this record on July 28, 2014