Clinical Trials Directory

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UnknownNCT05401474

Individualization Flow in Patients Treated With High Flow Nasal Therapy (iFLOW)

Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
26 (estimated)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask. The hypothesis is that this flow challenge (ROX index variation from 30 to 60L/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (ΔEELV), in patients treated with HFNC. It may allow to personalize the flow settings during HFNC. In this sense, an increase in EELV will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. In contrast, to increase the flow in non-responders (no significant increase in EELV with higher flows) increase the risk of patient self-inflicted lung injury (P-SILI).

Conditions

Interventions

TypeNameDescription
DEVICEHigh Flow Nasal Cannula at 30L/minFlow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
DEVICEHigh Flow Nasal Cannula at 45L/minFlow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range
DEVICEHigh Flow Nasal Cannula at 60L/minFlow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

Timeline

Start date
2022-03-18
Primary completion
2022-11-05
Completion
2023-02-28
First posted
2022-06-02
Last updated
2022-06-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05401474. Inclusion in this directory is not an endorsement.