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

NCT05089695 | Recruiting

• 1 other identifier: HENIVOT2
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Respiratory Failure; Hypoxemic Respiratory Failure

Keywords

Noninvasive ventilation; High-flow nasal oxygen; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Rate of Endotracheal intubation

  The proportion of patients requiring endotracheal intubation according to predefined criteria

  28 days

Secondary Outcomes (11)

• Days free of invasive mechanical ventilation at day 28

  28 days

• Days free of invasive mechanical ventilation at day 60

  60 days

• Days free of invasive mechanical ventilation at day 90

  90 days

• Rate of In-intensive care unit mortality

  90 days

• Rate of In-hospital care unit mortality

  90 days

Other Outcomes (2)

• Safety endpoint-causes of endotracheal intubation

  28 days

• Safety endpoint-time to treatment failure

  28 days

Study Arms (3)

Helmet Noninvasive ventilation (NIV)

EXPERIMENTAL

Patients in helmet noninvasive ventilation group will receive continuous helmet pressure support ventilation for at least 16 hours/day in the first 2 calendar days. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Each patient will be connected to a mechanical ventilator ventilator through a bitube circuit with no humidification. The ventilator will be set in PSV-NIV mode, with the following suggested settings \[34-38\]: 1. initial pressure support=12 cmH2O and adequate to permit a peak inspiratory flow of 100 l/min; 2. positive end-expiratory pressure=12 cmH2O. 3. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. 4. Inspiratory flow trigger = 2 l/min or according to the practice of each institution; 5. fastest pressurization time; 6. expiratory trigger: 10-50% of the maximum inspiratory flow, eventually modified to avoid double triggering; 7. maximum inspiratory time 1.2 second.

Device: Noninvasive respiratory support

Helmet continuous airway pressure (CPAP)

EXPERIMENTAL

Patients in CPAP group will receive continuous helmet CPAP for at least 16 hours/day in the first 2 calendar days. Continuous CPAP without interruptions will be strongly encouraged in the first 48 hours of treatment. Dedicated helmets for noninvasive ventilation will be applied and size will be chosen according to patient's neck circumference. Treatment will be delivered through a high-flow generator. The following settings will be applied: 1. Continuous air flow\>45 l/min. 2. Bi-tube circuit with no humidification, Y-piece with heat and moisture exchanger, or active heating and humidification with humidification chamber temperature set at 31 °C, 34 °C or 37 °C according to patients' comfort. 3. Expiratory positive end-expiratory pressure valve set to achieve PEEP=12 cmH2O. 4. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

Device: Noninvasive respiratory support

High-flow nasal oxygen

ACTIVE COMPARATOR

Initial set flow will be 50-60 l/min and flows will be decreased. in case of intolerance and/or according to patients' requirements: flows≥30 L/min will be mandatory in all enrolled patients. Humidification chamber will be set at 31 °C, 34 °C or 37 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%. Weaning the patient from high-flow will be considered only after 48 hours from enrolment and will be discouraged until the patients is considered for ICU discharge.

Device: Noninvasive respiratory support

Interventions

Noninvasive respiratory support DEVICE

Treatment of acute hypoxemic respiratory failure

Helmet Noninvasive ventilation (NIV); Helmet continuous airway pressure (CPAP); High-flow nasal oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Gemelli

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Domenico Luca Grieco, MD

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Massimo Antonelli, MD

  Fondazione Policlinico A. Gemelli IRCCS

  STUDY CHAIR

Central Study Contacts

Domenico Luca Grieco, MD

CONTACT

+393397681623; dlgrieco@outlook.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: With publication the results
• Access Criteria: Individual data will be made available by the principal investigator upon a reasonable request

Locations

IT (1)