Skip to main content
OpenTrials
Completed

NCT Number: NCT04333719

Prevalence of Deep Sedation in Terminal Palliative Phase

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Bordeaux - St André

Bordeaux, Aquitaine, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Describe the sedative therapies used

    Time frame: Day 1

    Comparative of sedative therapies used

  5. Describe the sedative therapies used

    Time frame: Day 31

    Comparative of sedative therapies used

  6. Describe the sedative therapies used

    Time frame: Day 60

    Comparative of sedative therapies used

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PREVAL-S2P

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.