- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00647361
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance
Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
-
Bern, Schweiz, 3010
- Department of Intensive Care Medicine, University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Male or female patients aged 18 - 85 years (extremes included)
- Mechanical ventilation (tracheally intubated or tracheotomized)
Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg
in 10 patients with impaired cardiac performance defined as either
- a left ventricular ejection fraction of < 40% and/or
- treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
- a cardiac index of ≤ 2.2 L•min-1•m2 and/or
- a pulmonary artery occlusion pressure (PAOP) ≥ 18 mmHg
in 10 patients with a history of chronic obstructive pulmonary disease (COPD) and delayed triggering-ON / cycling-OFF and/or evidence for wasted inspiratory efforts as evidenced by:
- limitation of expiratory air flow and intrinsic PEEP as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
- excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
- Presence of a pulmonary artery catheter and an arterial pressure line
- Subject itself or its next of kin has given written informed consent
Exclusion Criteria:
- Patient is less than 18 years or more than 80 years of age
- The attending physician refuses to allow enrollment
- The patient refuses informed consent
- Next of kin is unavailable or refuses informed consent
- Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
- Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
- Presence or suspicion of diaphragm injury
- Hemophilia or other severe bleeding disorder
- Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
- History of heart and/or lung transplantation
- Any mechanical cardiac assist device (including intraaortic balloon pump)
- Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
- The patient needs to be ventilated with a mode of MV controlling for tidal volume or for airway pressure as per attending physician.
- Severe hemodynamic instability as judged by the attending physician
- Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
- a fraction of inspired oxygen (FiO2) of > 0.8
- The patient currently participates in another interventional clinical trial
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: NAVA
|
Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Cardiac stroke volume index.
Zeitfenster: end of experimental periods
|
end of experimental periods
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Global delivery of oxygen
Zeitfenster: end of experimental period
|
end of experimental period
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Lukas Brander, MD, Department of Intensive Care Medicine, University Hospital - Inselspital, Bern, Switzerland
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
- Berger D, Bloechlinger S, Takala J, Sinderby C, Brander L. Heart-lung interactions during neurally adjusted ventilatory assist. Crit Care. 2014 Sep 12;18(5):499. doi: 10.1186/s13054-014-0499-8.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KEK BE 217-06
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .