Clinical trial NCT01572337: Early Non-invasive Ventilation Outside the Intensive Care Unit
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Acute Respiratory Failure
Keywords: NIV
acute respiratory failure
hypoxia
hypercapnia
non-invasive ventilation
hospital ward
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of patients who will need admission to the Intensive Care Unit care for severe acute respiratory failure
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University of Thessaly
city: Milan
country: Italy
facility: Ospedale San Raffaele di Milano
state: MI
city: Alessandria
country: Italy
facility: Ospedale Cesare Arrigo
state: Piemonte
city: Novara
country: Italy
facility: Ospedale di Novara
state: Piemonte
city: Asti
country: Italy
facility: Ospedale Civile di Asti
city: Brescia
country: Italy
facility: Spedali Civili
city: Genova
country: Italy
facility: Asl 3 Genovese
city: Genova
country: Italy
facility: Ospedali Galliera
city: Pisa
country: Italy
facility: AOU Pisana
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano
city: Roma
country: Italy
facility: Aurelia Hospital
city: Roma
country: Italy
facility: Policlinico A. Gemelli
city: Torino
country: Italy
facility: Azienda Ospedaliera San Giovanni Battista Molinette
city: Kazakhstan
country: Kazakhstan
facility: Astana Medical University
Study officials:
References:
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.
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.
citation: Monti G, Cabrini L, Kotani Y, Brusasco C, Kadralinova A, Giardina G, Chalkias A, Nakhnoukh C, Pantazopoulos I, Oliva FM, Dazzi F, Roasio A, Baiardo Redaelli M, Tripodi VF, Cucciolini G, Belletti A, Vaschetto R, Maj G, Borghi G, Savelli F, Boni S, D'Amico F, Cavallero S, Labanca R, Tresoldi M, Marmiere M, Marzaroli M, Moizo E, Monaco F, Nardelli P, Pieri M, Plumari V, Scandroglio AM, Turi S, Corradi F, Konkayev A, Landoni G, Bellomo R, Zangrillo A; NAVIGATE Study Group. Early noninvasive ventilation in general wards for acute respiratory failure: an international, multicentre, open-label, randomised trial. Br J Anaesth. 2025 Feb;134(2):382-391. doi: 10.1016/j.bja.2024.11.023. Epub 2025 Jan 2.
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.