Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy

Recruiting

• Conditions: High-flow Nasal Cannula; Ultrasound Evaluation; Diaphragm and Intercostal Muscle

• Registration Number: NCT06375538
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-21
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• more than 18 years old
• needing High-flow Nasal Cannula oxygenation therapy

Exclusion Criteria

• received mechanical ventilation, including invasive or noninvasive ventilation within one month prior to enrollment
• history of neuromuscular disorders (e.g., myasthenia gravis, Guillain-Barre syndrome);
• immediate endotracheal intubation is required (life-threatening hypoxemia)
• extensive damage to the thoracic skin (e.g., burns) unable to undergo ultrasonography
• pregnancy
• attending physician deemed it inappropriate to participate in the trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound evaluation of diaphragm	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	Thickness of the diaphragmatic muscle and the diaphragm thickening fraction (DTF) by ultrasound evaluation
The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation.	up to 30 days after High-flow Nasal Cannula (HFNC)oxygenation therapy.	Failing or not failing HFNC, the rate of needing noninvasive or intubated invasive mechanical ventilation.
Ultrasound evaluation of intercostal muscle movement index	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	the parasternal intercostal muscles thickening fraction by ultrasound evaluation

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	Oxygen saturation
oxygen concentration	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	oxygen concentration
flow velocity of HFNC	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	flow velocity of HFNC
ICU stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.	patients enrolled will be followed for length of ICU stay
all cause mortality	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.	all cause mortality
VT	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	VT
duration on HFNC	up to one month	patients enrolled for the duration of HFNC
Hospital stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.	patients enrolled will be followed for length of Hospital stay
respiratory rate	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.	respiratory rate

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China