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

NCT04502576 | Completed

• 1 other identifier: 4443
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

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.

Conditions

Respiratory Failure With Hypoxia

Outcome Measures

Primary Outcomes (1)

• Respiratory-support free days within 28 days from randomization

  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)

  28 days

Secondary Outcomes (11)

• Endotracheal intubation

  28 days

• Invasive ventilation-free days within 28 days from randomization

  28 days

• Invasive ventilation-free days within 60 days from randomization

  60 days

• Oxygenation

  28 days

• Carbon dioxide

  28 days

Study Arms (2)

High-flow nasal cannula

ACTIVE COMPARATOR

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

Helmet noninvasive ventilation

EXPERIMENTAL

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

Interventions

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

Helmet noninvasive ventilation; High-flow nasal cannula

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Università degli studi di Chieti: collaborator
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator

Study Sites (5)

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

Bologna, Italy

Location

SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara

Chieti, Italy

Location

Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara

Ferrara, Italy

Location

Infermi Hospital

Rimini, Italy

Location

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Location

Related Publications (2)

• Michi T, Mattana C, Menga LS, Bocci MG, Cesarano M, Rosa T, Gualano MR, Montomoli J, Spadaro S, Tosato M, Rota E, Landi F, Cutuli SL, Tanzarella ES, Pintaudi G, Piervincenzi E, Bello G, Tonetti T, Rucci P, De Pascale G, Maggiore SM, Grieco DL, Conti G, Antonelli M; Gemelli COVID-ICU study group. Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial. J Intensive Care. 2023 May 19;11(1):21. doi: 10.1186/s40560-023-00669-0.

  PMID: 37208787 DERIVED

• Grieco DL, Menga LS, Cesarano M, Rosa T, Spadaro S, Bitondo MM, Montomoli J, Falo G, Tonetti T, Cutuli SL, Pintaudi G, Tanzarella ES, Piervincenzi E, Bongiovanni F, Dell'Anna AM, Delle Cese L, Berardi C, Carelli S, Bocci MG, Montini L, Bello G, Natalini D, De Pascale G, Velardo M, Volta CA, Ranieri VM, Conti G, Maggiore SM, Antonelli M; COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 May 4;325(17):1731-1743. doi: 10.1001/jama.2021.4682.

  PMID: 33764378 DERIVED

Study Officials

• Domenico Luca Grieco, MD

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Massimo Antonelli, MD

  Fondazione Policlinico A. Gemelli IRCCS

  STUDY DIRECTOR

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: August 3, 2020
• First Posted: August 6, 2020
• Study Start: October 13, 2020
• Primary Completion: January 10, 2021
• Study Completion: December 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2021-10

Locations

IT (5)