Clinical trial NCT04502576: Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure
Official title: Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure: an Open Label, Pilot, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure With Hypoxia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Università degli studi di Chieti
name: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
First posted: 2020-08-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Respiratory-support free days within 28 days from randomization
timeFrame: 28 days
Secondary outcomes:
measure: Endotracheal intubation
timeFrame: 28 days
measure: Invasive ventilation-free days within 28 days from randomization
timeFrame: 28 days
measure: Invasive ventilation-free days within 60 days from randomization
timeFrame: 60 days
measure: Oxygenation
timeFrame: 28 days
measure: Carbon dioxide
timeFrame: 28 days
measure: Dyspnea
timeFrame: 28 days
measure: Respiratory rate
timeFrame: 28 days
measure: In-intensive care unit mortality
timeFrame: 90 days
measure: In-hospital mortality
timeFrame: 90 days
measure: 90-day mortality
timeFrame: 90 days
measure: Quality of life after recovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
city: Chieti
country: Italy
facility: SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
city: Ferrara
country: Italy
facility: Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
city: Rimini
country: Italy
facility: Infermi Hospital
city: Rome
country: Italy
facility: Fondazione Policlinico Universitaro A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Domenico Luca Grieco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Massimo Antonelli, MD
role: STUDY_DIRECTOR
References:
citation: 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.