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

NCT06375538 | Recruiting

• 1 other identifier: B2022-527
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• ICU stay

  up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.

• Hospital stay

  up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.

• all cause mortality

  up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.

• 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

  Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Ming Zhong

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Wu

CONTACT

13817976707; wu.wei1@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: October 21, 2022
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)