Who is sponsoring NCT04241861?

NCT04241861 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT04241861?

Interventions in NCT04241861: Respiratory support (High-flow oxygen therapy), Respiratory support (Helmet PSV), Respiratory support (Helmet CPAP).

What condition does NCT04241861 study?

NCT04241861 studies Respiratory Failure, Hypoxemia.

Is NCT04241861 still recruiting?

NCT04241861 is currently completed. Last updated 8 February 2021.

Last reviewed 2021-02-08 · How we verify

NCT04241861: HIGHFLOWHELMET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High-flow Nasal Cannula vs. Helmet PSV vs. Helmet CPAP During Respiratory Failure

Completed NA Last updated 8 February 2021

What this trial tests

NA trial testing Respiratory support (High-flow oxygen therapy) in Respiratory Failure in 15 participants. Completed in 27 January 2021.

Timeline

22 January 2020

Primary endpoint
27 January 2021

27 January 2021

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	22 January 2020
Primary completion	27 January 2021
Estimated completion	27 January 2021
Sites	1 location across Italy

Drugs / interventions tested

Respiratory support (High-flow oxygen therapy)
Respiratory support (Helmet PSV)
Respiratory support (Helmet CPAP)

Conditions studied

Respiratory Failure — all drugs for Respiratory Failure →
Hypoxemia — all drugs for Hypoxemia →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, any sex, with Respiratory Failure or Hypoxemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Respective Effects of Helmet Pressure Support, Continuous Positive Airway Pressure, and Nasal High-Flow in Hypoxemic Respiratory Failure: A Randomized Crossover Clinical Trial.
Menga LS, Delle Cese L, Rosà T, Cesarano M, et al · · 2023 · cited 59× · PMID 36378814 · DOI 10.1164/rccm.202204-0629oc
High-flow nasal cannulae for respiratory support in adult intensive care patients.
Corley A, Rickard CM, Aitken LM, Johnston A, et al · · 2017 · cited 44× · PMID 28555461 · DOI 10.1002/14651858.cd010172.pub2
High-flow nasal cannulae for respiratory support in adult intensive care patients.
Lewis SR, Baker PE, Parker R, Smith AF. · · 2021 · cited 43× · PMID 33661521 · DOI 10.1002/14651858.cd010172.pub3

Verify or expand the search:

Other recruiting trials for Respiratory Failure

Currently open trials in the same condition.

NCT07522450 — Benefit of Sleep Quality Monitoring by EEG in ICU · recruiting
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NCT07114289 — Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients · NA · recruiting
NCT06591533 — The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Proces · NA · recruiting

Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04241861 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 8 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04241861.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing