Predictors of HFNC Failure in Patients With AHRF Using Diaphragm Ultrasound

NCT06096376 | Completed

• 1 other identifier: UW 23-086-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

Acute Hypoxemic Respiratory Failure; High Flow Nasal Cannula; Diaphragm Ultrasound

Outcome Measures

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)

  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.

Interventions

Diaphragm Ultrasound DIAGNOSTIC_TEST

Diaphragm ultrasound to assess respiratory muscle function and respiratory efficiency

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Adult Intensive Care Unit

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: April 28, 2023
• Primary Completion: June 26, 2024
• Study Completion: September 1, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

HK (1)