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Effects of a New Interface for NIV on Respiratory Drive

NCT04619667 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-11-16

No results posted yet for this study

Summary

This pilot physiologic randomized cross-over study was designed to investigate if, in patients with hARF, a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) reduces the respiratory effort, as compared to HFNC and CPAP alone (first outcome). Furthermore, the diaphragm activation, as assessed with ultrasound, gas exchange and patient's comfort among different settings will be assessed (secondary outcomes).

Conditions

  • Acute Respiratory Failure

Interventions

DEVICE

Continuous Positive Airway Pressure (CPAP)

CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet

DEVICE

High Flow Nasal Cannula (HFNC)

HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Federico Longhini, MD · Magna Graecia University, Anesthesia and Intensive Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04619667 on ClinicalTrials.gov