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

High-flow Nasal Cannula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06375538
• Other study ID #: B2022-527
• Status: Recruiting
• Start date: October 21, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Wei Wu
• Phone: 13817976707
• Email: wu.wei1[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High-flow Nasal Cannula
• Ultrasound Evaluation

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound evaluation of diaphragm	Thickness of the diaphragmatic muscle and the diaphragm thickening fraction (DTF) by ultrasound evaluation	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
Primary	Ultrasound evaluation of intercostal muscle movement index	the parasternal intercostal muscles thickening fraction by ultrasound evaluation	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
Primary	The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation.	Failing or not failing HFNC, the rate of needing noninvasive or intubated invasive mechanical ventilation.	up to 30 days after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary	ICU stay	patients enrolled will be followed for length of ICU stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary	Hospital stay	patients enrolled will be followed for length of Hospital stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary	all cause mortality	all cause mortality	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary	Oxygen saturation	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.
Secondary	respiratory rate	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.
Secondary	oxygen concentration	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.
Secondary	flow velocity of HFNC	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.
Secondary	VT	VT	Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
Secondary	duration on HFNC	patients enrolled for the duration of HFNC	up to one month