Critical IllnessLDNCT07559669
Study on the Measurement Method of the Left Diaphragm
An observational study of Critical Illness, run by Shanghai Zhongshan Hospital.
Trial summary
This study intends to use ultrasound to measure the bilateral diaphragmatic ultrasound indicators in critically ill patients, focusing on the left diaphragm, and to explore the consistency and reliability among various ultrasound indicators to evaluate the diaphragmatic mobility Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Critically ill patients
Who may be able to join
- ①Adult patients (≥18 years old) of both sexes;
- In invasive group, intubation or tracheotomy was changed to 5L/min T-tube or tracheotomy mask oxygen inhalation;
- Patients in non-invasive group were treated with mask oxygen 5L/min;
- agree to participate in the trial and sign the informed consent;
Who cannot join
- ①The diaphragm ultrasound operation site was too large to obtain images.
- Diaphragmatic ultrasound images could not be obtained in any section;
- The ultrasound image quality of any section was poor;
- the presence of phrenic nerve injury/paralysis ⑤ pregnant women; ⑥ Neuromuscular diseases such as ALS and myasthenia gravis affect the evaluation of spontaneous breathing ⑦ Patients deemed by the investigator to be ineligible.
About this study
Official title: To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients
This study intends to use ultrasound to measure the bilateral diaphragmatic ultrasound indicators in critically ill patients, focusing on the left diaphragm, and to explore the consistency and reliability among various ultrasound indicators to evaluate the diaphragmatic mobility
- Conditions
- Critical Illness
- Keywords
- Diaphragm ultrasound, critical illness
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| Invasive respiratory support group | The subjects of ultrasound measurement were patients with invasive mechanical ventilation | |
| Noninvasive respiratory support group | The subjects of ultrasound measurement were patients with non-invasive respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.
The main purpose is to verify the consistency of the two methods, Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
Measured: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
Secondary outcomes (2)
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.
Consistency of measurement methods，Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
Measured: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
Consistency of diaphragmatic excursion measurements between the standard position and the other five positions on the right side.
Consistency of measurement methods，Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
Measured: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start5 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559669
- Sponsor's protocol ID
- B2026-162
- Acronym
- LD
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07559669
- Acronym / sponsor ID
- LD / B2026-162
- Conditions
- Critical Illness
- Keywords
- Diaphragm ultrasound, critical illness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 2026 (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.
This study intends to use ultrasound to measure the bilateral diaphragmatic ultrasound indicators in critically ill patients, focusing on the left diaphragm, and to explore the consistency and reliability among various ultrasound indicators to evaluate the diaphragmatic mobility
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive respiratory support group | – | –The subjects of ultrasound measurement were patients with invasive mechanical ventilation |
| Noninvasive respiratory support group | – | –The subjects of ultrasound measurement were patients with non-invasive respiratory support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (4 listed)
- ①Adult patients (≥18 years old) of both sexes;
Key exclusion criteria (4 listed)
- ①The diaphragm ultrasound operation site was too large to obtain images.
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
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.
Time frame: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
The main purpose is to verify the consistency of the two methods, Measurements were performed after switching patients in the invasive group (intubated patients to T-piece oxygen at 5 L/min and tracheostomized patients to face mask oxygen at 5 L/min following weaning), and patients in the non-invasive group (those receiving non-invasive ventilation or high-flow oxygen therapy) to conventional face mask oxygen at 5 L/min.
2 secondary outcomes
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.
Time frame: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
Consistency of diaphragmatic excursion measurements between the standard position and the other five positions on the right side.
Time frame: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Shanghai Zhongshan Hospital.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side. (time frame: Measurements were performed 5 minutes after all patients were switched to conventional oxygen therapy at 5 L/min for the first time, once breathing had stabilized.). 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 30 Apr 2026.