- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Bern, Svizzera, 3010
- Department of Intensive Care Medicine, University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: NAVA
|
Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Cardiac stroke volume index.
Lasso di tempo: end of experimental periods
|
end of experimental periods
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Global delivery of oxygen
Lasso di tempo: end of experimental period
|
end of experimental period
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Lukas Brander, MD, Department of Intensive Care Medicine, University Hospital - Inselspital, Bern, Switzerland
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KEK BE 217-06
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .