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

NCT05401474 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-06-02

No results posted yet for this study

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

  • High-Flow Nasal Cannula
  • Oxygen Therapy
  • Acute Respiratory Failure
  • Respiratory Failure
  • Lung Injury

Interventions

DEVICE

High Flow Nasal Cannula at 30L/min

Flow will be set at 30L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

DEVICE

High Flow Nasal Cannula at 45L/min

Flow will be set at 45L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

DEVICE

High Flow Nasal Cannula at 60L/min

Flow will be set at 60L/min, FiO2 will be adjusted manually to maintain SpO2within the target range

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2022-11-05
Completion
2023-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT05401474 on ClinicalTrials.gov