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

Primary Purpose

Early Acute Respiratory Failure

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Non-invasive ventilation
Standard care
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Early Acute Respiratory Failure focused on measuring NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ospedale San Raffaele di MilanoRecruiting
  • Ospedale Cesare ArrigoRecruiting
  • Ospedale di NovaraRecruiting
  • Ospedale Civile di AstiRecruiting
  • Spedali CiviliRecruiting
  • Asl 3 GenoveseRecruiting
  • Ospedali GallieraRecruiting
  • Aurelia HospitalRecruiting
  • Policlinico A. Gemelli
  • Azienda Ospedaliera San Giovanni Battista Molinette
  • Astana Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NIV

Best available treatment

Arm Description

Non-invasive ventilation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 16, 2012
Last Updated
December 23, 2022
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01572337
Brief Title
Early Non-invasive Ventilation Outside the Intensive Care Unit
Acronym
NAVIGATE
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 Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Acute Respiratory Failure
Keywords
NIV, acute respiratory failure, hypoxia, hypercapnia, non-invasive ventilation, hospital ward

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIV
Arm Type
Experimental
Arm Description
Non-invasive ventilation
Arm Title
Best available treatment
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Non-invasive ventilation
Other Intervention Name(s)
Noninvasive ventilation, NIV
Intervention Description
Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure
Intervention Type
Other
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Landoni
Email
landoni.giovanni@hsr.it
Facility Information:
Facility Name
Ospedale San Raffaele di Milano
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni
Email
landoni.giovanni@hsr.it
Facility Name
Ospedale Cesare Arrigo
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Racca, MD
First Name & Middle Initial & Last Name & Degree
Giulia Maj, MD
Email
giulia.maj@ospedale.al.it
Facility Name
Ospedale di Novara
City
Novara
State/Province
Piemonte
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanna Vaschetto
Email
rosanna.vaschetto@med.uniupo.it
Facility Name
Ospedale Civile di Asti
City
Asti
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agostino Roasio, MD
Facility Name
Spedali Civili
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Filippini, MD
Facility Name
Asl 3 Genovese
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Ferrara, MD
Facility Name
Ospedali Galliera
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Corradi, MD
Facility Name
Aurelia Hospital
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Cotticelli, MD
Facility Name
Policlinico A. Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Antonelli
Facility Name
Azienda Ospedaliera San Giovanni Battista Molinette
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Ranieri
Facility Name
Astana Medical University
City
Kazakhstan
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aidos Konkayev, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24444661
Citation
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.
Results Reference
background
PubMed Identifier
24364004
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.
Results Reference
background
PubMed Identifier
30739002
Citation
Cabrini L, Brusasco C, Roasio A, Corradi F, Nardelli P, Filippini M, Cotticelli V, Belletti A, Ferrera L, Antonucci E, Baiardo Redaelli M, Lattuada M, Colombo S, Olper L, Ponzetta G, Ananiadou S, Monti G, Severi L, Maj G, Giardina G, Biondi-Zoccai G, Benedetto U, Gemma M, Cavallero SSM, Hajjar LA, Zangrillo A, Bellomo R, Landoni G. Non-invAsive VentIlation for early General wArd respiraTory failurE (NAVIGATE): A multicenter randomized controlled study. Protocol and statistical analysis plan. Contemp Clin Trials. 2019 Mar;78:126-132. doi: 10.1016/j.cct.2019.02.001. Epub 2019 Feb 7.
Results Reference
derived

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Early Non-invasive Ventilation Outside the Intensive Care Unit

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