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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096363
Other study ID # UW 23-086-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 28, 2023
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source Queen Mary Hospital, Hong Kong
Contact Wincy Ng, MRCP
Phone 22553111
Email wincyngwingsze@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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