NCT06096363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 13, 2023

Last Update Submit

October 15, 2024

Conditions

Keywords

EchocardiographyAcute Hypoxemic Respiratory FailureHigh Flow Nasal Cannula

Outcome Measures

Primary Outcomes (1)

  • High-flow nasal cannula (HFNC) therapeutic failure

    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.

Interventions

Transthoracic Echocardiography to look for evidence of right ventricular (RV) dysfunction and right ventricular-pulmonary arterial (RV-PA) uncoupling.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 echocardiographic image quality for data processing; OR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

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 16, 2024

Record last verified: 2024-10

Locations