Clinical trial NCT04333719: Prevalence of Deep Sedation in Terminal Palliative Phase
Official title: Prevalence of Deep Sedation in Terminal Palliative Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Deep Sedations
Keywords: palliative care
prevalence
terminal phase
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 183
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Determine the number of patient with deep sedation
timeFrame: Day 1
measure: Determine the number of patient with deep sedation
timeFrame: Day 31
measure: Determine the number of patient with deep sedation
timeFrame: Month 60
Secondary outcomes:
measure: Determine the number of patient by type of disease
timeFrame: Day 1
measure: Determine the number of patient by type of disease
timeFrame: Day 31
measure: Determine the number of patient by type of disease
timeFrame: Day 60
measure: Describe the sedative therapies used
timeFrame: Day 1
measure: Describe the sedative therapies used
timeFrame: Day 31
measure: Describe the sedative therapies used
timeFrame: Day 60
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - St André
state: Aquitaine
Study officials:
affiliation: University Hospital, Bordeaux
name: Benoît BURUCOA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: