Palliative CarePREVAL-S2PNCT04333719
Prevalence of Deep Sedation in Terminal Palliative Phase
An observational study of Palliative Care and Deep Sedations, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Palliative Care, Deep Sedations
- What is being tested?
- Type of sedations
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2020to 17 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Bordeaux - St André
Bordeaux, Aquitaine, 33000
About this study
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.
Read the 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.
- Conditions
- Palliative Care, Deep Sedations
- Being tested
- Type of sedations
- Keywords
- palliative care, prevalence, terminal phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of sedationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| terminally ill patients in specialized palliative | terminally ill patients in specialized palliative care facilities Receives: Other: Type of sedations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 60
Secondary outcomes (6)
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
Measured: Day 1
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
Measured: Day 31
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
Measured: Day 60
Describe the sedative therapies used
Comparative of sedative therapies used
Measured: Day 1
Describe the sedative therapies used
Comparative of sedative therapies used
Measured: Day 31
Describe the sedative therapies used
Comparative of sedative therapies used
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start13 Sep 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît BURUCOA, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333719
- Sponsor's protocol ID
- CHUBX 2019/02
- Acronym
- PREVAL-S2P
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Deep Sedation in Terminal Palliative Phase
- ClinicalTrials.gov ID
- NCT04333719
- Acronym / sponsor ID
- PREVAL-S2P / CHUBX 2019/02
- Conditions
- Palliative Care, Deep Sedations
- Keywords
- palliative care, prevalence, terminal phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 Sep 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| terminally ill patients in specialized palliative | – | Other: Type of sedationsterminally ill patients in specialized palliative care facilities |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of sedationsEstimate 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 | Other | terminally ill patients in specialized palliative |
Primary outcome
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.
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.
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.
6 secondary outcomes
Determine the number of patient by type of disease
Time frame: Day 1
Determine the number of patient by type of disease
Time frame: Day 31
Determine the number of patient by type of disease
Time frame: Day 60
Describe the sedative therapies used
Time frame: Day 1
Describe the sedative therapies used
Time frame: Day 31
Describe the sedative therapies used
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît BURUCOA, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Deep Sedations, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of patient with deep sedation (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.