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Study on the Measurement Method of the Left Diaphragm (LD)

23 de abril de 2026 atualizado 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Doença grave

Tipo de estudo

Observacional

Inscrição (Estimado)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Critically ill patients

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side. Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side. Prazo: 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. Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Zhongshan Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de maio de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

12 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de abril de 2026

Primeira postagem (Real)

30 de abril de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)