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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06375538

Enrollment

200

Registered

2024-04-19

Start date

2022-10-21

Completion date

2025-12-31

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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 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

Secondary

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

Countries

China

Contacts

Primary ContactWei Wu

wu.wei1@zs-hospital.sh.cn13817976707

Outcome results