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

Respiratory Failure Clinical Trial

— HENIVOT2  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05089695
• Other study ID #: HENIVOT2
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Domenico Luca Grieco, MD
• Phone: +393397681623
• Email: dlgrieco[@]outlook.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The optimal initial management of acute hypoxemic respiratory failure is uncertain. Helmet noninvasive ventilation and high-flow nasal oxygen appear as the most promising techniques in this setting. Recently, the first head-to-head randomized trial compared first-line continuous treatment with helmet pressure support ventilation with specific settings (PEEP=12 cmH2O pressure and pressure support=10-12 cmH2O) vs. high-flow nasal oxygen alone in patients with moderate-to-severe hypoxemic respiratory failure. Results showed no significant inter-group difference in the days free of respiratory support at 28 days, but lower intubation rate and increased 28-day invasive ventilation-free days in the helmet group. Use of helmet noninvasive ventilation is less frequent than use of helmet continuous positive airway pressure, which is simpler to use. The investigators designed an open-label, multicentre randomized trial to assess the effect of helmet pressure support ventilation and continuous airway pressure as compared to high-flow nasal oxygen on the intubation rate of patients with moderate-to-severe hypoxemic respiratory failure in the intensive care unit.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive respiratory support
Treatment of acute hypoxemic respiratory failure

Locations

Country	Name	City	State
Italy	Gemelli	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Catholic University of the Sacred Heart, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Country where clinical trial is conducted

Italy, 

Outcome

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