- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07586345
The Effectiveness of Different Nebulized Solutions on Airway Clearance Function in Patients With Pneumonia
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Diagnosed with pneumonia, defined by ICD-10 codes, including:
J18: Pneumonia, unspecified organism J180: Bronchopneumonia, unspecified organism J181: Lobar pneumonia, unspecified organism J182: Hypostatic pneumonia, unspecified organism J188: Other pneumonia, unspecified organism J189: Pneumonia, unspecified organism
- Aged 18-100 years
- Clinical respiratory score > 3
- Patients unable to expectorate sputum spontaneously and requiring assisted suctioning
Exclusion Criteria:
Diagnosis of influenza-associated pneumonia, defined by ICD-10 codes, including:
J09X1: Influenza due to identified novel influenza A virus with pneumonia J1001: Influenza due to other identified influenza virus with the same identified influenza viral pneumonia J100: Influenza due to other identified influenza virus with pneumonia
Diagnosis of COVID-19 infection, defined by ICD-10 code:
U07.1: COVID-19, virus identified
- History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
- History of lung cancer or metastatic cancer involving the lungs
- Current use of bronchodilators
- Patients requiring oral suctioning only
- Oxygen therapy with a flow rate > 10 L/min
- Clinical respiratory score > 8 (Table 2)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Kontrolgruppe
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
Aktiv komparator: Hypertonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
Aktiv komparator: Isotonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
Aktiv komparator: Hypotonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vein blood gas
Tidsramme: Measurements were performed before the intervention and at 7 days after the intervention.
|
Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
|
Sputum routine examination
Tidsramme: Measurements were performed before the intervention and at 7 days after the intervention.
|
Assessment of sputum characteristics and routine laboratory findings.
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
|
Arterial oxygen content (CaO₂)
Tidsramme: Measurements were performed before the intervention and at 7 days after the intervention.
|
Measurement of arterial oxygen content calculated from hemoglobin concentration, oxygen saturation, and partial pressure of oxygen. Unit of Measure: mL O₂/dL blood |
Measurements were performed before the intervention and at 7 days after the intervention.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood lactic acid level
Tidsramme: Measurements were performed before the intervention and at 7 days after the intervention.
|
Measurement of serum lactic acid concentration.
Unit of Measure: mmol/L
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TSGH-SS_D_115024
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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