Respiratory Failure Clinical Trial
— HENIVOT2Official title:
Helmet Noninvasive Ventilation vs. Continuous Positive Airway Pressure vs. High-flow Nasal Oxygen as First-line Treatment of Acute Hypoxemic Respiratory Failure (HENIVOT2). An Open-label, Multicentre Randomized Trial
NCT number | NCT05089695 |
Other study ID # | HENIVOT2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | June 2026 |
Multicenter, open label, three-arm randomized trial to assess the effect of helmet noninvasive ventilation vs. helmet continuous positive airway pressure vs. high-flow nasal oxygen on the rate of endotracheal intubation of patients with acute moderate-to-severe hypoxemic respiratory failure
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Acute symptoms of respiratory failure PaO2/FiO2 ratio = 200; PaCO2=45mmHg; Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency (NYHA>2 or left ventricular ejection fraction<50%); Informed consent Patients that have already received NIV, CPAP continuously for more than 24 hours before the screening visit will be excluded. Other Exclusion Criteria: - Pregnancy; - Exacerbation of asthma or chronic obstructive pulmonary disease; - Hypercapnia (PaCO2>45 mmHg) with or without respiratory acidosis; - More than 2 organ failures, including the lung. - Documented pneumothorax; - Clinical diagnosis of Cardiogenic pulmonary edema; - Haemodynamic instability (Systolic blood pressure<90 mmHg or mean arterial pressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinically diagnosed Shock requiring administration of vasoactive agents (norepinephrine>0.1 mcg/Kg/min); - Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia); - Chronic kidney failure requiring dialysis before ICU admission; - Chronic hypoxemic respiratory failure requiring long-term oxygen therapy; - Altered neurological status that requires immediate intubation and/or making the patient uncooperative; - Urgent need for endotracheal intubation, according to the decision of the attending physician; - Do not intubate order; - Decision of withdrawal of life-sustaining therapy; - Thoracic or abdominal surgery in the previous 7 days; - Any condition that makes the patient very likely to require endotracheal intubation due to a reason different from respiratory failure; - Recent head surgery or anatomy that prevent the application of helmet or HFNC to patient's face. |
Country | Name | City | State |
---|---|---|---|
Italy | Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Catholic University of the Sacred Heart, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety endpoint-causes of endotracheal intubation | Among patients meeting the primary endpoint, the cause of noninvasive treatment failure (as defined by the predefined intubation criteria) | 28 days | |
Other | Safety endpoint-time to treatment failure | In patients meeting the primary endpoint, the time (hours) from randomization to intubation | 28 days | |
Primary | Rate of Endotracheal intubation | The proportion of patients requiring endotracheal intubation according to predefined criteria | 28 days | |
Secondary | Days free of invasive mechanical ventilation at day 28 | The number of days in which patients do not receive mechanical ventilation within 28 days from randomization | 28 days | |
Secondary | Days free of invasive mechanical ventilation at day 60 | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization | 60 days | |
Secondary | Days free of invasive mechanical ventilation at day 90 | The number of days in which patients do not receive mechanical ventilation within 60 days from randomization | 90 days | |
Secondary | Rate of In-intensive care unit mortality | All-cause mortality, assessed at the discharge from the intensive care unit | 90 days | |
Secondary | Rate of In-hospital care unit mortality | All-cause mortality, assessed at the discharge from the hospital | 90 days | |
Secondary | Rate of 90-day mortality | All-cause 90-day mortality | 90 days | |
Secondary | 90-day ICU free days | The days not spent in the intensive care unit by the patient on a 90-day basis | 90 days | |
Secondary | 90-day hospital free days | The days not spent in the hospital by the patient on a 90-day basis | 90 days | |
Secondary | Incidence of pneumonia | Incidence of pneumonia, diagnosed after the treatment start and during the ICU stay | 90 days | |
Secondary | Incidence of shock | Incidence of shock, diagnosed after treatment start and during the ICU stay | 90 days | |
Secondary | Incidence of barotrauma | Incidence of barotrauma, defined as pneumothorax o pneumomediastinum after treatment start and during the ICU stay | 90 days |
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