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RECRUITINGNANCT06483984

Noninvasive Ventilation Facemasks Favoring Carbon Dioxide Washout

The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hyp...

Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS•2 locations•View source on ClinicalTrials.gov

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Contacts

Domenico Luca Grieco, MD

CONTACT

+39063015 domenicoluca.grieco@unicatt.it

Sponsors

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Acute respiratory failure with
•PaCO2 ≥ 45 mmHg;
•Arterial pH \< 7.35;
•Signed written informed consent

Exclusion Criteria

•Respiratory rate \< 12 bpm;
•Immediate need for intubation;
•Haemodynamic instability (Systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) and/or lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
•Metabolic Acidosis;
•Recent head surgery or anatomy that prevent the application of facemasks;
•Any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (EIT) belt placement.
•Any contraindications to facemask noninvasive ventilation.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 30, 2025Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment20

Start dateNov 2024

Last updatedSep 30, 2025

Condition

Respiratory Insufficiency

Locations shown

General intensive care unit, Fondazione Policlinico A. Gemelli IRCCS

Roma

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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