RecruitingNot ApplicableNCT05089695

Helmet NIV vs. CPAP vs. High-flow Nasal Oxygen in Hypoxemic Respiratory Failure

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

1,200 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Respiratory Failure Hypoxemic Respiratory Failure

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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.

Exclusion Criteria17

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.