- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07559669
Study on the Measurement Method of the Left Diaphragm (LD)
To Study the Consistency of Multiple Measurement Methods of Left Diaphragm Mobility in Critically Ill Patients
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Consistency of diaphragmatic mobility measurements between the standard and modified positions on the left side.
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Consistency of diaphragmatic excursion measurements between the standard position and the other four positions on the left side.
Tidsramme: 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.
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2026-162
Plan for individuelle deltagerdata (IPD)
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