CompletedPhase 4

Early Non-invasive Ventilation Outside the Intensive Care Unit

Greece, Italy, Kazakhstan520 participantsStarted 2012-04

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 gastrointestina…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT01572337

SponsorUniversità Vita-Salute San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-17

View on ClinicalTrials.gov More Early Acute Respiratory Failure trials