End Of Life in the Critically Ill patiEnt

Intensive Care Unit Syndrome Clinical Trial

— EOLE  

Official title:

End Of Life in the Critically Ill patiEnt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392857
• Other study ID #: EOLE
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: February 13, 2019

Study information

• Verified date: October 2018
• Source: French Society for Intensive Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this multicentric study is to evaluate the perception of the quality of the end of life in intensive care units seen from the side of the caregivers, trough the CAESAR scale.

Description:

More than 20% of deaths occur in hospital after a stay in intensive care units; up to half of them happens as result of a treatment limitation. Ensuring end-of-life quality is important, not only because is a moral duty of all caregivers, but also to prevent negative effects in close relatives of dead patients.

In an assessment of quality of in-hospital deaths involving 3793 patients, only 35% of the deaths were judged to be of acceptable quality by the nurses.

Assessment tools have been developed recently on this topic. Most studies have focused on the perception of end-of-life quality by close relatives, particularly through the CAESAR scale in the most recent one.

The main purpose of this multicentric study is to evaluate the perception of the quality of the end-of-life in intensive care units seen from the side of the caregivers, in relation to the new French legislative framework.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: February 13, 2019
• Est. primary completion date: October 16, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Caregivers of intensive care unit whose patient has recently deceased

Exclusion Criteria:

• Refusal of participation by caregivers

• Refusal of participation by family of deceased patient

• Patient in cardiac arrest at the time of ICU admission.

• Age of deceased patient was under 18 years

• Patient in brain death

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit Syndrome
• Terminal Illness

Intervention

Other:
• Assessment by caregivers of the quality of the end of life in intensive care units
Quality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale.

Locations

Country	Name	City	State
France	Hôpital Saint-Esprit	Agen
France	Centre Hospitalier Alès en Cévennes	Alès
France	CHU Amiens	Amiens
France	CHU d'Angers	Angers
France	Hopital Privé d'Antony	Antony
France	CH d'Argenteuil	Argenteuil
France	Hopital Mercy	Ars-Laquenexy
France	Centre Hospitalier René Dauffaut	Avignon
France	Hopital Nord Franche Comté	Belfort
France	CHU Besancon	Besançon
France	CH Germon et Gauthier	Beuvry
France	Hopital Avicenne	Bobigny
France	CHU Pellegrin	Bordeaux
France	Hopital St-Andre	Bordeaux
France	Hopital Ambroise Pare	Boulogne Billancourt
France	Centre Hospitalier fleyriat	Bourg-en-Bresse
France	CHRU de la Cavale Blanche	Brest
France	HIA Clermont Tonnerre	Brest
France	CHU Caen	Caen
France	Centre Hospitalier Jean Rougie	Cahors
France	CH Charleville	Charleville-Mézières
France	HIA Percy	Clamart
France	Hopital Antoine Beclere	Clamart
France	Hopital Louis Mourier	Colombes
France	Centre Hospitalier Compiègne Noyon	Compiègne
France	CH Sud Francilien	Corbeil-Essonnes
France	Groupe Hospitalier Sud Ile de France	Corbeil-Essonnes
France	Clinique des Cèdres	Cornebarrieu
France	CHU Henri Mondor	Creteil
France	Centre Hospitalier de Dax	Dax
France	Centre Hospitalier de Dieppe	Dieppe
France	CHU Dijon Bourgogne	Dijon
France	Centre Hospitalier de la Dracénie	Draguignan
France	Centre Hospitalier Victor Jousselin	Dreux
France	Hopital Simone Veil	Eaubonne
France	Centre Hospitalier Sud Essonne	Étampes
France	Centre Hospitalier Communal des Alpes du Sud	Gap
France	Hopital Raymond Poincare	Garches
France	Centre Hospitalier Avranche Granville	Granville
France	CHU Grenoble Alpes	Grenoble
France	Centre Hospitalier de Gueret	Guéret
France	Centre Hospitalier de Haguenau	Haguenau
France	Grand Hopital de l'Est Francilien	Jossigny
France	Centre Hospitalier des 2 Vallées	Juvisy-sur-Orge
France	CHU Réunion Saint Pierre	La Réunion
France	CHD Les Oudairies	la Roche sur Yon
France	Centre Hospitalier La Rochelle	La Rochelle
France	CH de Versailles	Le Chesnay
France	CHU Kremlin-Bicetre	Le Kremlin-Bicêtre
France	CH Le Mans	Le Mans
France	Hopital Roger Salengro	Lille
France	Centre hospitalier Saint Philibert	Lomme
France	Centre Hospitalier Bretagne Sud	Lorient
France	CH St-Joseph St-Luc	Lyon
France	Groupe Hospitalier Edouard Herriot	Lyon
France	HIA Desgenettes Lyon	Lyon
France	Hopital Francois Quesnay	Mantes-la-Jolie
France	CHU Marseille Hopital Nord	Marseille
France	Hopital de la Timone	Marseille
France	Hopital Européen Marseille	Marseille
France	CH de Meaux	Meaux
France	Hopital Notre-Dame de Bon Secours	Metz
France	Centre Hospitalier de Mont de Marsan	Mont-de-Marsan
France	GHIRM	Montfermeil
France	CHU Lapeyronie	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Hopital Laennec	Nantes
France	American Hospital of Paris	Neuilly-sur-Seine
France	Hopital l'Archet	Nice
France	CHU Nimes	Nîmes
France	CHR d'Orléans Hopital la Source	Orléans
France	CHU Necker Enfants Malades	Paris
France	CHU Robert Debré	Paris
France	Cochin	Paris
France	GH Diaconnesses Croix Saint Simon	Paris
France	HEGP	Paris
France	Hopital St Louis	Paris
France	Hopital Tenon	Paris
France	Institut Mutualiste Montsouris	Paris
France	La Pitié Salpetriere	Paris
France	CH Francois Miterrand	Pau
France	CH Poissy	Poissy
France	CHU Poitiers	Poitiers
France	CH de Pontoise	Pontoise
France	CH de la Région d'Annecy	Pringy
France	CH Leon Binet	Provins
France	Hopital Privé Claude Galien	Quincy-sous-Sénart
France	CHRU Reims	Reims
France	CHG Rochefort	Rochefort
France	Centre Cardiologique du Nord	Saint-Denis
France	Clinique de l'Union	Saint-Jean
France	Hopital Saint Clair	Sète
France	CH de St-Brieuc	St-Brieuc
France	Hopital Delafontaine	St-Denis
France	CH de St-Malo	St-Malo
France	HIA Béjin	St-Mande
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse Rangueil	Toulouse
France	CHRU Bretonneau	Tours
France	Hopital Privé du Vert Galan	Tremblay-en-France
France	Centre Hospitalier de Troyes	Troyes
France	Centre Hospitalier de Valenciennes	Valenciennes
France	Hopital Jean Bernard	Valenciennes
France	Centre Hospitalier Bretagne Atlantique	Vannes
France	Centre hospitalier André Mignot	Versailles
France	Centre Hospitalier de Vichy	Vichy
France	Institut Gustave Roussy	Villejuif
France	Institut Gustave Roussy	Villejuif
France	HIA Robert Pique	Villenave-d'Ornon
France	Centre Hospitalier Lucie et Raymond Aubrac	Villeneuve-Saint-Georges
France	Hopital Privé du Val d'Yerres	Yerres

Sponsors (2)

Lead Sponsor	Collaborator
French Society for Intensive Care	CHU Nantes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15 items questionnaire CAESAR	The CAESAR scale assesses perceptions of palliative stage of patient's pathology, of patient's comfort, of presence and care of close relatives, with a score for each item ranging from 1 (traumatic experience) to 5 (soothing). The purpose of our study is to assess the perception of end-of-life quality seen from the caregivers' side, using the CAESAR scale.	Depending of end-of-life duration, usually 6 hours.
Secondary	Variables associated with the perception by caregivers of end-of-life quality	Evaluate the variables associated with the perception by caregivers of end-of-life quality: proportion of treatment limitations, frequencies of conflicts between close relatives of dead patients and caregivers, frequencies end-of-life deep sedations, detailed description of current sedation practices, proportion of treatments, monitoring and blood tests maintained after treatment limitation during end-of-life .	time needed for the enrollment of caregivers of 5 to 15 consecutive deceased patients per center (depending on the size of the center): usually 1 month
Secondary	Analogic visual scale (0 to 10)	Analogic visual scale on end-of-life quality seen from the caregiver's side	Depending of end-of-life duration, usually 6 hours.