- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01953484
Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal
In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans.
Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Milan, Italien, 20122
- Rekruttering
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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Ledende efterforsker:
- Stefania Crotti, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Acute Respiratory Insufficiency
- Extracorporeal gas exchange support
- The patient is spontaneously breathing (including assisted ventilation)
Exclusion Criteria:
- age below 18 yrs
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Acute Respiratory Distress Syndrome
Acute hypoxemia, bilateral pulmonary infiltrates and no evidence of primary left atrial hypertension
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Eksperimentel: Chronic Obstructive Pulmonary Disease
Acute-on-Chronic Respiratory Insufficiency (patients with Chronic Obstructive Pulmonary Disease)
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Eksperimentel: Bridge to Lung Transplant
Acute-on-Chronic Respiratory Insufficiency (patients awaiting lung transplant)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spontaneous ventilation
Tidsramme: 30-60 minutes after changing extracorporeal carbon dioxide removal
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Extracorporeal carbon dioxide removal will be increased or decreased changing the gas flow to the extracorporeal membrane lung.
Actual extracorporeal carbon dioxide removal will be measured.
Spontaneous respiratory rate, tidal volume, minute ventilation, esophageal pressure swings and comfort of the patient will be recorded 30-60 minutes after changing extracorporeal carbon dioxide removal.
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30-60 minutes after changing extracorporeal carbon dioxide removal
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VECLA-ECMO
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