Clinical trial NCT06375538: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy
Official title: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High-flow Nasal Cannula
Ultrasound Evaluation
Diaphragm and Intercostal Muscle
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged above 18 who are admitted to ICU will be screened for eligibility.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound evaluation of diaphragm
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: Ultrasound evaluation of intercostal muscle movement index
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation.
timeFrame: up to 30 days after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary outcomes:
measure: ICU stay
timeFrame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
measure: Hospital stay
timeFrame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
measure: all cause mortality
timeFrame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
measure: Oxygen saturation
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: respiratory rate
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: oxygen concentration
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: flow velocity of HFNC
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: VT
timeFrame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
measure: duration on HFNC
timeFrame: up to one month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Ming Zhong
role: PRINCIPAL_INVESTIGATOR
References: