Diaphragm UltrasoundNCT04355559
The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy
An observational study of Diaphragm Ultrasound and Intensive Care Unit, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Ultrasound, Intensive Care Unit
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Aug 2020
- 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 older than 18 years without Invasive mechanical ventilation when entering the intensive care unit.
Who may be able to join
- patients older than 18 years
- without Invasive mechanical ventilation when entering the intensive care unit.
Who cannot join
- have noninvasive ventilation or high flow nasal cannula contraindications
- history of neuromuscular disease chest wall deformities
- previously assessed diaphragmatic palsy
- shock or severe hemodynamic instability
- known pregnancy, and/or need for immediate endotracheal intubation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
lixin xie, doctor
About this study
Official title: Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.
Read the detailed description
- the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve. diaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time
- Conditions
- Diaphragm Ultrasound, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conventional oxygen therapy | Continuous use of current oxygen therapy | |
| high flow nasal cannula | change the oxygen therapy to high flow nasal cannula | |
| Noninvasive ventilation | change the oxygen therapy to noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the data diaphragmatic ultrasound
Record the data at the baseline and intervention
Measured: When the intervention which is the first time to change the oxygen therapy
Secondary outcomes (1)
Arterial blood gas analysis results
Record the data at the baseline and intervention
Measured: When the intervention which is the first time to change the oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Aug 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm UltrasoundStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355559
- Sponsor's protocol ID
- 2018TM-03
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
- ClinicalTrials.gov ID
- NCT04355559
- Acronym / sponsor ID
- 2018TM-03
- Conditions
- Diaphragm Ultrasound, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 21 Apr 2020 (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.
In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.
Detailed description
- the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve. diaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional oxygen therapy | – | –Continuous use of current oxygen therapy |
| high flow nasal cannula | – | –change the oxygen therapy to high flow nasal cannula |
| Noninvasive ventilation | – | –change the oxygen therapy to noninvasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients older than 18 years without Invasive mechanical ventilation when entering the intensive care unit.
Key inclusion criteria (2 listed)
- patients older than 18 years
- without Invasive mechanical ventilation when entering the intensive care unit.
Key exclusion criteria (5 listed)
- have noninvasive ventilation or high flow nasal cannula contraindications
- history of neuromuscular disease chest wall deformities
- previously assessed diaphragmatic palsy
- shock or severe hemodynamic instability
- known pregnancy, and/or need for immediate endotracheal intubation
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
the data diaphragmatic ultrasound
Time frame: When the intervention which is the first time to change the oxygen therapy
Record the data at the baseline and intervention
1 secondary outcome
Arterial blood gas analysis results
Time frame: When the intervention which is the first time to change the oxygen therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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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.
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 Diaphragm Ultrasound and Intensive Care Unit, run by Chinese PLA General 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 5 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 21 Apr 2020. 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 ruoxuan wen, Respiratory therapist (15801216687, 905508797@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the data diaphragmatic ultrasound (time frame: When the intervention which is the first time to change the oxygen therapy). 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 21 Apr 2020.