High-flow Nasal CannulaNCT06375538
Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy
An observational study of High-flow Nasal Cannula and Ultrasound Evaluation, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-flow Nasal Cannula, Ultrasound Evaluation, Diaphragm and Intercostal Muscle
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged above 18 who are admitted to ICU will be screened for eligibility.
Who may be able to join
- more than 18 years old
- needing High-flow Nasal Cannula oxygenation therapy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Wei Wu, 13817976707, wu.wei1@zs-hospital.sh.cn
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound evaluation of diaphragm
Thickness of the diaphragmatic muscle and the diaphragm thickening fraction (DTF) by ultrasound evaluation
Measured: 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
Measured: 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.
Measured: up to 30 days after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Secondary outcomes (9)
ICU stay
patients enrolled will be followed for length of ICU stay
Measured: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Hospital stay
patients enrolled will be followed for length of Hospital stay
Measured: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
all cause mortality
all cause mortality
Measured: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Oxygen saturation
Oxygen saturation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start21 Oct 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-flow Nasal CannulaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhong, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375538
- Sponsor's protocol ID
- B2022-527
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy
- ClinicalTrials.gov ID
- NCT06375538
- Acronym / sponsor ID
- B2022-527
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 18 who are admitted to ICU will be screened for eligibility.
Key inclusion criteria (2 listed)
- more than 18 years old
- needing High-flow Nasal Cannula oxygenation therapy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasound evaluation of diaphragm
Time frame: 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
Ultrasound evaluation of intercostal muscle movement index
Time frame: 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.
Time frame: 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.
9 secondary outcomes
ICU stay
Time frame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Hospital stay
Time frame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
all cause mortality
Time frame: up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.
Oxygen saturation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.
VT
Time frame: 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
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhong principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-flow Nasal Cannula and Ultrasound Evaluation, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wu (13817976707, wu.wei1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound evaluation of diaphragm (time frame: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.