Study on the Measurement Method of the Left Diaphragm

NCT07559669 | Not Yet Recruiting

• 1 other identifier: B2026-162
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Critical Illness

Keywords

Diaphragm ultrasound; critical illness

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 30, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04