Prevalence of Deep Sedation in Terminal Palliative Phase

Palliative Care Clinical Trial

— PREVAL-S2P  

Official title:

Prevalence of Deep Sedation in Terminal Palliative Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333719
• Other study ID #: CHUBX 2019/02
• Status: Completed
• Start date: September 13, 2020
• Est. completion date: November 17, 2020

Study information

• Verified date: January 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: November 17, 2020
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Deep Sedations
• Palliative Care

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux - St André	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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