Prevalence of Deep Sedation in Terminal Palliative Phase

NCT04333719 | Completed

• 1 other identifier: CHUBX 2019/02
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

This nation-wide, multicentric, prospective and cross-sectional study aims to estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility (palliative care units, dedicated beds in acute units, mobile teams for inpatient or outpatients or home-based structures) in France.

Conditions

Palliative Care; Deep Sedations

Keywords

palliative care; prevalence; terminal phase

Outcome Measures

Primary Outcomes (3)

• Determine the number of patient with deep sedation

  The primary endpoint will be the prevalence of deep sedations among all the included patients with a terminal disease receiving cares from a specialized palliative care facility.

  Day 1

• Determine the number of patient with deep sedation

  The primary endpoint will be the prevalence of deep sedations among all the included patients with a terminal disease receiving cares from a specialized palliative care facility.

  Day 31

• Determine the number of patient with deep sedation

  The primary endpoint will be the prevalence of deep sedations among all the included patients with a terminal disease receiving cares from a specialized palliative care facility.

  Month 60

Secondary Outcomes (6)

• Determine the number of patient by type of disease

  Day 1

• Determine the number of patient by type of disease

  Day 31

• Determine the number of patient by type of disease

  Day 60

• Describe the sedative therapies used

  Day 1

• Describe the sedative therapies used

  Day 31

Study Arms (1)

terminally ill patients in specialized palliative

terminally ill patients in specialized palliative care facilities

Other: Type of sedations

Interventions

Type of sedations OTHER

Estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility

terminally ill patients in specialized palliative

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Major, minor, major with legal protection patient, follow-up by a specialized palliative care facility, palliative situation of a disease (non-curable) in terminal palliative phase (life expectancy estimated by the investigator =\< 4 weeks)

You may qualify if:

• Major, minor, major with legal protection patient
• Follow-up by a specialized palliative care facility;
• Palliative situation of a disease (non-curable);
• In terminal palliative phase (life expectancy estimated by the investigator =\< 4 weeks)

You may not qualify if:

• Not followed by a specialized palliative care facility;
• In curative situation (curable);
• In non-terminal palliative phase (life expectancy estimated by the investigator \> 4 weeks).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux - St André

Bordeaux, Aquitaine, 33000, France

Location

Study Officials

• Benoît BURUCOA, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: September 13, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)