- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02659228
Assessing Covert Consciousness in Unresponsive Patients
25. oktober 2016 opdateret af: George Mashour, University of Michigan
Assessing the Potential for 'Covert Consciousness' in Unresponsive Patients
In this study, the investigators explore anesthesia as a tool for providing further insight into the level of consciousness of individuals with a clinical diagnosis of unresponsive wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious awareness.
This group, who could potentially be conscious, will herein be referred to as the target population.
Our goal is to assess whether or not neurological patterns of consciousness in the target population respond to anesthesia in a similar manner to neurologically compromised individuals with known consciousness (e.g.
those in minimally conscious state (MCS).
In healthy controls, propofol-induced unconsciousness results in an elimination of the mismatch negativity event-related brain potential (ERP) and a diminished directed connectivity.
The investigators hypothesize that at doses well below those required for surgery, anesthesia will have similar effects on these neural patterns in neurologically compromised patients with the potential for conscious awareness, but will not affect these patterns in those who lack consciousness.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Patients admitted to the intensive care unit at Hamilton General Hospital who:
- Clinical status consistent with UWS (no responsiveness to commands)
- Clinical status consistent with MCS (minimal response to at least one command)
- Presence of an endotracheal tube (ETT) or a tracheostomy tube
- Between 18 and 50 years of age
Exclusion Criteria:
• Elevated intracranial pressure (ICP)
- Hepatic or renal failure
- Hemodynamic instability
- Active vasopressor therapy
- Previous open-head injury
- Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours
- Anticipated ICU stay < 24 hours
- Documented allergy to propofol
- Pregnancy
- BMI > 35 kg/m2
- Anyone who is deemed medically unsuitable for this study by the attending intensivist
- Patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Control 1 (negative control)
Individuals with a diagnosis of UWS without neural markers of consciousness
|
EEG recording with anesthetic (DIPRIVAN)
|
Aktiv komparator: Control 2 (positive control)
Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness
|
EEG recording with anesthetic (DIPRIVAN)
|
Eksperimentel: Target Population
Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness
|
EEG recording with anesthetic (DIPRIVAN)
The participant will receive an intravenous infusion of propofol (DIPRIVAN Injectable Emulsion USP 1%, AstraZeneca).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Asymmetry in feedback vs. feedforward network connectivity
Tidsramme: 3 hours
|
EEG networks will be monitored pre, during and post anesthesia.
Directed connectivity will be calculated using phase lag index (PLI) and symbolic transfer entropy (STE) between all combinations of EEG sensors.
Average values of feedback connectivity (e.g. from the frontal regions to parietal and occipital regions) will be compared to average values of feedforward connectivity (e.g. from parietal and occipital regions to frontal regions).
Positive asymmetry will be correlated to the presence of conscious awareness and negative asymmetry will be correlated to the absence of conscious awareness.
|
3 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Presence of P300 and N400 event-related potentials
Tidsramme: 3 hours
|
EEG signals will be processed to extract the event-related EEG reactions to the auditory stimulation paradigm.
Signals will be average 300 ms post-stimuli and 400 ms post-stimuli to assess the presence of the P300 and N400 event-related potentials.
Presence of these event-related potentials will be correlated to the presence of conscious awareness and absence of these event-related potentials will be correlated to the absence of conscious awareness.
|
3 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2016
Primær færdiggørelse (Forventet)
1. juni 2017
Datoer for studieregistrering
Først indsendt
8. januar 2016
Først indsendt, der opfyldte QC-kriterier
14. januar 2016
Først opslået (Skøn)
20. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Bevidsthedsforstyrrelser
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Bedøvelsesmidler, intravenøst
Andre undersøgelses-id-numre
- 13-784
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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