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Completed

NCT Number: NCT03392857

End Of Life in the Critically Ill patiEnt

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Esprit, Agen, France

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About this study

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.

Who can participate

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

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

Treatment and study plan

Assessment by caregivers of the quality of the end of life in intensive care units

Other

Quality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale.

Primary outcomes

  1. 15 items questionnaire CAESAR

    Time frame: Depending of end-of-life duration, usually 6 hours.

    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.

Secondary outcomes

  1. Variables associated with the perception by caregivers of end-of-life quality

    Time frame: 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

    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 .

  2. Analogic visual scale (0 to 10)

    Time frame: Depending of end-of-life duration, usually 6 hours.

    Analogic visual scale on end-of-life quality seen from the caregiver's side

Sponsors and collaborators

Lead sponsor

French Society for Intensive Care

Other

Collaborators

  • Nantes University Hospital

Registry information

Acronym: EOLE

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 8, 2018
Registry last updated
Feb 15, 2019

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.

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