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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03273244
Date of registration: 28/08/2017
Prospective Registration: No
Primary sponsor: Vrije Universiteit Brussel
Public title: Measuring Comfort During Palliative Sedation COMPAS
Scientific title: Towards a Better Understanding of What Palliative Sedated Patients Experience: Linking Numbers to Experiences
Date of first enrolment: May 12, 2017
Target sample size: 12
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03273244
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Belgium
Contacts
Name:     Reginald Deschepper, PhD
Address: 
Telephone:
Email:
Affiliation:  Vrije Universiteit Brussel
Key inclusion & exclusion criteria

Inclusion Criteria:

Patients may be included if they are considered by their treating physician as:

1. in their last week of life

2. in conditions that might, when not treated, cause high levels of distress

3. sedated

4. unable to communicate

Exclusion Criteria:

-



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Palliative Sedation
Intervention(s)
Device: NeuroSense monitoring and ANI monitoring
Primary Outcome(s)
Level of awareness [Time Frame: From date of enrollment until the date of death, on average less than 1 week.]
Level of pain and discomfort [Time Frame: From date of enrollment until the date of death, on average less than 1 week.]
Secondary Outcome(s)
Awareness [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.]
Awareness [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.]
Pain [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.]
Communication [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.]
Communication [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.]
Pain [Time Frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.]
Secondary ID(s)
FWOAL768
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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