Status:
COMPLETED
Helmet Noninvasive Ventilation vs. High-flow Nasal Cannula in Moderate-to-severe Acute Hypoxemic Respiratory Failure
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborating Sponsors:
Università degli studi di Chieti
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Conditions:
Respiratory Failure With Hypoxia
Eligibility:
All Genders
18+ years
Phase:
NA
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 randomi...
Eligibility Criteria
Inclusion
- Acute-onset respiratory distress or flue-related symptoms Moderate-to-severe hypoxemia (PaO2/FiO2\<=200 mmHg) PaCO2\<45 mmHg pH\>7.30
Exclusion
- 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
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04502576
Start Date
October 13 2020
End Date
December 1 2022
Last Update
January 3 2024
Active Locations (5)
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1
Policlinico di Sant'Orsola, Alma Mater Studiorum-Università di Bologna
Bologna, Italy
2
SS. Annunziata Hospital, Gabriele d'Annunzio University of Chieti-Pescara
Chieti, Italy
3
Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara
Ferrara, Italy
4
Infermi Hospital
Rimini, Italy