Predictors of HFNC Failure in Patients With AHRF Using Diaphragm Ultrasound (ULTRAFLOW)

October 15, 2024 updated by: Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong

Predictors of High-Flow Nasal Cannula Failure (HFNC) in Patients With Acute Hypoxemic Respiratory Failure (AHRF) Using Diaphragm Ultrasound Parameters

Ultrasound of the diaphragm is an easily reproducible bedside tool that provides a non-invasive measurement of inspiratory muscle function and respiratory efficiency. The diaphragmatic thickness correlates with the strength and muscle shortening and is reflective of its contribution to the respiratory workload. Diaphragm thickening fraction (DTF) has been shown to be predictive of extubation failure in ventilated patients. However, whether measurements of DTF are predictive of high flow nasal cannula (HFNC) outcomes in patients with acute hypoxemic respiratory failure (AHRF) remains unknown. The objective of this study is to identify predictors of HFNC failure by diaphragm ultrasound and to compare its performance with the well-established ROX index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from acute hypoxemic respiratory requiring ventilatory support with high flow nasal cannula

Description

Inclusion Criteria:

  • Age ≧ 18; AND
  • Acute hypoxemic respiratory failure (AHRF), defined by respiratory rate of greater than 25 breaths per minute and a ratio of the PaO2 to the fraction of inspired oxygen (PaO2 / FiO2) of less than 300, and use of accessory muscles of respiration or paradoxical abdominal motion; AND
  • Required ventilatory support with high-flow nasal cannula (HFNC)

Exclusion Criteria:

  • Patients suffering from hypercapnic respiratory failure; OR
  • AHRF secondary to conditions that are indicated for non-invasive ventilation (NIV) (e.g. acute exacerbation of COPD, cardiogenic pulmonary edema); OR
  • Use of NIV or invasive mechanical ventilation (IMV) prior to HFNC initiation; OR
  • Patients with imminent need for endotracheal intubation and invasive mechanical ventilation (IMV); OR
  • Patients with known or suspected diaphragm paralysis; OR
  • Pregnancy; OR
  • Patients with abdominal compartment syndrome; OR
  • Use of HFNC for more than 12 hours prior to ICU admission; OR
  • Patients with suboptimal diaphragm ultrasound image quality for data processing; OR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High flow nasal cannula (HFNC) therapeutic failure
Time Frame: From the start of recruitment into study (i.e. start of HFNC use), till the date of study endpoint (i.e., step up to non-invasive ventilation, intubation, death on HFNC, or weaned off HFNC, whichever came first), assessed up to 4 weeks.
Predictive value of diaphragm ultrasound in detecting high flow nasal cannula (HFNC)therapeutic failure in patients with acute hypoxemic respiratory failure (AHRF)
From the start of recruitment into study (i.e. start of HFNC use), till the date of study endpoint (i.e., step up to non-invasive ventilation, intubation, death on HFNC, or weaned off HFNC, whichever came first), assessed up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 23-086-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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