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NCT Number: NCT04502576

Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure

Helmet noninvasive ventilation and high-flow nasal cannula are novel tools for the first-line treatment of acute hypoxemic respiratory failure. Compared to face-mask noninvasive ventilation in randomized trials, both have improved clinical outcome of patients with moderate-to-severe hypoxemic respiratory failure.

As compared to high-flow nasal cannula, helmet noninvasive ventilation improves oxygenation, reduces inspiratory effort, respiratory rate and dyspnea. Whether these physiological benefits are translated into improved outcome remains to be established.

The investigators designed a randomized trial to establish whether first line treatment with Helmet noninvasive ventilation is capable of increasing the number of 28-day respiratory-support-free days, as compared to high-flow nasal cannula in patients with moderate-to-severe acute hypoxemic respiratory failure.

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Key information

Conditions

Respiratory Failure With Hypoxia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna, Bologna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2<=200 mmHg) PaCO2<45 mmHg pH>7.30

Exclusion criteria

Need for urgent endo-tracheal intubation Exacerbation of asthma or chronic obstructive pulmonary disease Documented pneumothorax Clinical diagnosis of Cardiogenic pulmonary oedema Do-not-intubate order Altered neurological status that requires immediate intubation and/or making the patient uncooperative Thoracic or abdominal surgery in the previous 7 days Recent head surgery or anatomy that prevent the application of helmet or Optiflow to patient's face

Treatment and study plan

Noninvasive respiratory support

Device

In both arms, the treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge.

Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit

Primary outcomes

  1. Respiratory-support free days within 28 days from randomization

    Time frame: 28 days

    The number of days in which patients did not receive any form of respiratory support (i.e. high-flow nasal cannula, noninvasive ventilation, invasive mechanical ventilation)

Secondary outcomes

  1. Endotracheal intubation

    Time frame: 28 days

    The proportion of patients requiring endotracheal intubation in the two groups. The need for endotracheal intubation will be established with predefined criteria, which will be evaluated a posteriori by an independent adjudication committee

  2. Invasive ventilation-free days within 28 days from randomization

    Time frame: 28 days

    The number of days in which patients did not receive invasive mechanical ventilation

  3. Invasive ventilation-free days within 60 days from randomization

    Time frame: 60 days

    The number of days in which patients did not receive invasive mechanical ventilation

  4. Oxygenation

    Time frame: 28 days

    The ratio of PaO2 to FiO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge

  5. Carbon dioxide

    Time frame: 28 days

    PaCO2 will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge

  6. Dyspnea

    Time frame: 28 days

    Dyspnea will be evaluated through a visual analog scale (0-10, where 10 represents the most sever symptom) will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge

  7. Respiratory rate

    Time frame: 28 days

    Respiratory rate will be measured 1, 6, 12, 24 hours after randomization and then once daily up to intensive care unit discharge

  8. In-intensive care unit mortality

    Time frame: 90 days

    Clinical outcome (dead/alive) at intensive care unit discharge

  9. In-hospital mortality

    Time frame: 90 days

    Clinical outcome (dead/alive) at hospital discharge

  10. 90-day mortality

    Time frame: 90 days

    Clinical outcome (dead/alive) at 90 days after randomization

  11. Quality of life after recovery

    Time frame: 1 year

    Quality of life in survivors, assessed by Short Form-36 questionnaire

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
  • Università degli studi di Chieti

Registry information

Official study title

Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial

Acronym: HENIVOTpilot

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 6, 2020
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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