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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Wei Wu; Phone Number: 13817976707; Email: wu.wei1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Contact: Wei Wu; Phone Number: 13817976707; Email: wu.wei1@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients aged above 18 who are admitted to ICU will be screened for eligibility.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay	patients enrolled will be followed for length of ICU stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Hospital stay	patients enrolled will be followed for length of Hospital stay	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
all cause mortality	all cause mortality	up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
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.
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.
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.
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.
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.
duration on HFNC	patients enrolled for the duration of HFNC	up to one month

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Ming Zhong, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B2022-527

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No