AHRF-ECHO: Predictors of HFNC Failure in Patients With AHRF Using Echocardiography Parameters

• Sponsor: Queen Mary Hospital, Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06096363
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 16.2
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Hypoxemic Respiratory Failure	Diagnostic Test: Transthoracic Echocardiography

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictors of High-Flow Nasal Cannula Failure (HFNC) in Patients With Acute Hypoxemic Respiratory Failure (AHRF) Using Echocardiography Parameters
• Actual Study Start Date: Apr 28, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Outcome Measures

Primary Outcome Measures

1. High-flow nasal cannula (HFNC) therapeutic failure [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Queen Mary Hospital, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wincy Wing-Sze Ng, Associate Consultant, Adult Intensive Care Unit, Queen Mary Hospital, Hong Kong
• ClinicalTrials.gov Identifier: NCT06096363
• Other Study ID Numbers: UW 23-086-01
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wincy Wing-Sze Ng, Associate Consultant, Adult Intensive Care Unit, Queen Mary Hospital, Hong Kong: Echocardiography; Acute Hypoxemic Respiratory Failure; High Flow Nasal Cannula
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Oct 25, 2023