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CompletedNCT06096376ULTRAFLOWUpdated Oct 17, 2024

Predictors of HFNC Failure in Patients With AHRF Using Diaphragm Ultrasound

An observational study in Acute Hypoxemic Respiratory Failure, sponsored by Queen Mary Hospital, Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Queen Mary Hospital, Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Hypoxemic Respiratory Failure

Keywords

  • Acute Hypoxemic Respiratory Failure
  • High Flow Nasal Cannula
  • Diaphragm Ultrasound
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 30 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Queen Mary Hospital, Hong Kong is the lead sponsor of 24 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • Diagnostic testDiaphragm Ultrasound

    Diaphragm ultrasound to assess respiratory muscle function and respiratory efficiency

06

What researchers measure

Primary outcomes

  1. High flow nasal cannula (HFNC) therapeutic failure

    Predictive value of diaphragm ultrasound in detecting high flow nasal cannula (HFNC)therapeutic failure in patients with acute hypoxemic respiratory failure (AHRF)

    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.

07

Study locations

1 site
  • Queen Mary Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06096376
Lead sponsor
Queen Mary Hospital, Hong Kong
Responsible party
Wincy Wing-Sze Ng (Associate Consultant, Adult Intensive Care Unit, Queen Mary Hospital, Hong Kong) — Principal investigator
First posted
Oct 23, 2023
Start date
Apr 28, 2023
Primary completion
Jun 26, 2024
Completion
Sep 1, 2024
Last update
Oct 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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