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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502576
Recruitment Status : Active, not recruiting
First Posted : August 6, 2020
Last Update Posted : November 19, 2021
Sponsor:
Collaborators:
Università degli studi di Chieti
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Respiratory Failure With Hypoxia Device: Noninvasive respiratory support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial
Actual Study Start Date : October 13, 2020
Actual Primary Completion Date : January 10, 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-flow nasal cannula

High-flow nasal cannula will be delivered with the Optiflow system. Initial set flow will be ≥ 50 /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 (MR860, Fisher and Paykel healthcare, New Zealand) will be set at 37 °C or 34 °C according to patient's comfort. FiO2 will be titrated to obtain an SpO2≥92% and ≤98%.

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. Weaning from high-flow will be considered as standardized criteria are met.

Device: Noninvasive respiratory support

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


Experimental: Helmet noninvasive ventilation

Patients will receive continuous helmet pressure support ventilation for at least 16 hours/day the first 2 calendar days. Continuous noninvasive ventilation without interruptions will be strongly encouraged in the first 24 hours of treatment. The ventilator will be set in pressure support mode. Use of continuous positive airway pressure by flow generators and Venturi systems instead of pressure support ventilation will be allowed in case of shortage of ventilators. Maintenance of positive end-expiratory pressure ≥ 8-10 during the treatment is mandatory.

After weaning and during any interruption from noninvasive ventilation, patients will undergo low-flow or high-flow oxygen, according to the decision of the attending physician.

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.

Device: Noninvasive respiratory support

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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502576


Locations
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Italy
Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
Bologna, Italy
SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
Chieti, Italy
Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
Ferrara, Italy
Infermi Hospital
Rimini, Italy
Fondazione Policlinico Universitaro A. Gemelli IRCCS
Rome, Italy
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Università degli studi di Chieti
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Investigators
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Principal Investigator: Domenico Luca Grieco, MD Fondazione Policlinico A. Gemelli IRCCS
Study Director: Massimo Antonelli, MD Fondazione Policlinico A. Gemelli IRCCS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04502576    
Other Study ID Numbers: 4443
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be made available upon a reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory