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

Last updated: January 2, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Failure

Lung Injury

Treatment

Noninvasive respiratory support

Clinical Study ID

NCT05089695
HENIVOT2
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Acute symptoms of respiratory failure PaO2/FiO2 ratio ≤ 200; PaCO2≤45mmHg; Absence ofhistory 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 beforethe screening visit will be excluded.

Exclusion

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 arterialpressure<65mmHg) and/or lactic acidosis (lactate>5 mmol/L) and/or clinically diagnosedShock 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 thepatient uncooperative;
  • Urgent need for endotracheal intubation, according to the decision of the attendingphysician;
  • 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 intubationdue to a reason different from respiratory failure;
  • Recent head surgery or anatomy that prevent the application of helmet or HFNC topatient's face.

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Noninvasive respiratory support
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Gemelli

    Rome,
    Italy

    Active - Recruiting

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