Study on the Measurement Method of the Left Diaphragm (LD)
23 de abril de 2026 actualizado por: Shanghai Zhongshan Hospital
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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
35
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Critically ill patients
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.
Periodo de tiempo: 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.
|
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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.
Periodo de tiempo: 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.
|
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.
Periodo de tiempo: 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.
|
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.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B2026-162
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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