- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06096363
Predictors of HFNC Failure in Patients With AHRF Using Echocardiography Parameters (AHRF-ECHO)
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 Echocardiography Parameters
Right ventricular dysfunction (RVD) and right ventricular-pulmonary arterial (RV-PA) uncoupling detected by transthoracic echocardiography (TTE) in acute respiratory distress syndrome (ARDS) are associated with poor survival.
Early detection of RVD and RV-PA uncoupling in patients with acute hypoxemic respiratory failure (AHRF) may be indicative of worsening and decompensating pulmonary condition which may require escalation of respiratory support.
The use of TTE parameters in predicting high-flow nasal cannula (HFNC) failure has not been previously studied.
The objective of this study is to identify predictors of HFNC failure by TTE and to compare its performance with the well-established ROX index.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
28
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
-
-
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Hong Kong, Hong Kong
- Queen Mary Hospital
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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 echocardiographic 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 transthoracic echocardiography (TTE) 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
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 16, 2024
Last Update Submitted That Met QC Criteria
October 15, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 23-086-01
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.