Study on the Measurement Method of the Left Diaphragm

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

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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;

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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.

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 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.
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.

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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients

Acronym: LD

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 30, 2026
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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