Prevalence of Deep Sedation in Terminal Palliative Phase (PREVAL-S2P)

January 20, 2021 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inducing a deep sedation in palliative care is a sensitive practice. The abolition of the communication in a crucial moment of life for the patients is particularly challenging. This practice implies particular experiences for families and caregivers, often increased by the deepness of the sedation. In France, the Claeys-Leonetti law has added additional indications of deep sedation. The lack of data on the prevalence of this practice in palliative care complicates the implementation of research projects and the improvement of professionals skills. In existing literature, the proportions of patients thus sedated varied from 2.5 to 14.5%. To our knowledge, no study on the prevalence of deep sedative practices in terminal diseases has been carried out in France. This observational study will help to better understand the real importance of this practice among each palliative care structures. They will also serve to build research projects on this theme supporting improvement of care for this population.

In this study, the deep sedation is defined as a sedation directly inducing from the induction time a score of -4 or -5 at the Richmond vigilance scale (or a clinically equivalent state for the investigator) as defined by the French society of palliative care and accompanying.

The day of inclusion, the investigator will collect the information about the structure of palliative care (type, team composition, number of patients with an on-going terminal disease), the characteristics of the sedated patient(s) (age, disease, treatments) and of the sedation (sedative molecules, assessment of vigilance, consents and decision-making process). In case of an on-going sedation previously initiated but still in progress the day of inclusion, the investigator will retrospectively collect the required data.

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Centre Hospitalier Universitaire de Bordeaux - St André

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
terminally ill patients in specialized palliative
terminally ill patients in specialized palliative care facilities
Other: Type of sedations
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the number of patient with deep sedation
Time Frame: Day 1
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
Time Frame: Day 31
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
Time Frame: Month 60
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the number of patient by type of disease
Time Frame: Day 1
deep palliative sedations for each sub-group of duration, depth and consent regarding the SEDAPALL classification
Day 1
Determine the number of patient by type of disease
Time Frame: Day 31
deep palliative sedations for each sub-group of duration, depth and consent regarding the SEDAPALL classification
Day 31
Determine the number of patient by type of disease
Time Frame: Day 60
deep palliative sedations for each sub-group of duration, depth and consent regarding the SEDAPALL classification
Day 60
Describe the sedative therapies used
Time Frame: Day 1
Comparative of sedative therapies used
Day 1
Describe the sedative therapies used
Time Frame: Day 31
Comparative of sedative therapies used
Day 31
Describe the sedative therapies used
Time Frame: Day 60
Comparative of sedative therapies used
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Benoît BURUCOA, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2020

Primary Completion (Actual)

November 17, 2020

Study Completion (Actual)

November 17, 2020

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUBX 2019/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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