- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02576132
Pupillometry for Pain Assessment in Critically Ill Patients
This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.
Being in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.
However, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.
The primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Berlin, Niemcy, 13353
- Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- critically ill patients
- aged 18 years or older
- patients with an expected intensive care unit length of stay of of at least 48 hours.
Exclusion Criteria:
- not German speaking
- traumatic brain injury
- stroke
- increased intracranial pressure
- ocular disease or surgery.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Correlation coefficient of pupillary light reflex amplitude and pain score
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Pain is measured by Numeric Rating Scale - Visualised or Behavioural Pain Scale or Behavioral Pain Scale - Non Intubated and pupillary light reflex amplitude is measured by pupillometry
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Participants will be followed up to 6 days during their intensive care unit stay
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Minimal pupil size [mm]
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Maximal pupil size [mm]
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Contraction speed of pupil [mm/s]
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Latency of pupil [ms]
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Pupillary light reflex [%]
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Richmond Agitation Sedation Scale (RASS)
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Glasgow Coma Scale (GCS)
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Delirium
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
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Participants will be followed up to 6 days during their intensive care unit stay
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Duration of mechanical ventilation (hours)
Ramy czasowe: Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
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Intensive care unit length of stay (days)
Ramy czasowe: Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
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Hospital length of stay (days)
Ramy czasowe: Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Hospital mortality (days)
Ramy czasowe: Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Discharge to home [%]
Ramy czasowe: Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Morbidity Scores
Ramy czasowe: Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
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Amount of administered drugs
Ramy czasowe: Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Claudia Spies, MD Prof., Charité - Univeritätsmedizin Berlin
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Vola-ICU
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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