Pupillometry for Pain Assessment in Critically Ill Patients
13 octobre 2015 mis à jour par: Claudia Spies, Charite University, Berlin, Germany
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
80
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 13353
- Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Critically ill patients, aged 18 years or older with an expected intensive care unit length of stay of of at least 48 hours.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Correlation coefficient of pupillary light reflex amplitude and pain score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Minimal pupil size [mm]
Délai: 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]
Délai: 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]
Délai: 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]
Délai: 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 [%]
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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 [%]
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Claudia Spies, MD Prof., Charité - Univeritätsmedizin Berlin
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2011
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 octobre 2012
Dates d'inscription aux études
Première soumission
9 octobre 2015
Première soumission répondant aux critères de contrôle qualité
13 octobre 2015
Première publication (Estimation)
15 octobre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 octobre 2015
Dernière vérification
1 octobre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Vola-ICU
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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