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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05817500
Other study ID # 29BRC21.0335 - CoPRADA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 9, 2021
Est. completion date December 9, 2022

Study information

Verified date April 2023
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation.


Description:

After a stay in intensive care units (ICU), patients can experience physical, psychological and cognitive impairments. To assess this post intensive care syndrom (PICS), post-ICU consultation have been developed. Since 5 year mortality is higher in ICU survivors, it might be interesting to address those patients' views relating to illness and end of life through a discussion on advance directives (AD), during post-ICU consultation. However, the development of these consultations being recent, it has not yet been assessed whether this consultations might be a suitable time to discuss AD and the intensivit a suitable interlocutor.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 9, 2022
Est. primary completion date December 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with 48 hours of mechanical ventilation - Patients with a 5 days stay in ICU Exclusion Criteria: - Patients with therapeutic limitation discussed during their ICU stay - Geographical remotness to come to the post-ICU consultation - Minor patients - Patient not affiliated to the social security scheme

Study Design


Locations

Country Name City State
France CHU Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (3)

Andreu P, Dargent A, Large A, Meunier-Beillard N, Vinault S, Leiva-Rojas U, Ecarnot F, Prin S, Charles PE, Fournel I, Rigaud JP, Quenot JP. Impact of a stay in the intensive care unit on the preparation of Advance Directives: Descriptive, exploratory, qualitative study. Anaesth Crit Care Pain Med. 2018 Apr;37(2):113-119. doi: 10.1016/j.accpm.2017.05.007. Epub 2017 Aug 4. — View Citation

Lone NI, Walsh TS. Impact of intensive care unit organ failures on mortality during the five years after a critical illness. Am J Respir Crit Care Med. 2012 Oct 1;186(7):640-7. doi: 10.1164/rccm.201201-0059OC. Epub 2012 Jul 26. — View Citation

Rousseau AF, Prescott HC, Brett SJ, Weiss B, Azoulay E, Creteur J, Latronico N, Hough CL, Weber-Carstens S, Vincent JL, Preiser JC. Long-term outcomes after critical illness: recent insights. Crit Care. 2021 Mar 17;25(1):108. doi: 10.1186/s13054-021-03535-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients willing to discuss AD after an ICU stay Number of patient willing to discussion AD after ICU stay will be observed 1 year
Secondary Number of patients knowing about AD before their ICU stay Number of patient knowing before AD before ICU stay will be observed 1 year
Secondary Factors influencing the writing of AD after an ICU stay Factors such as lenght of stay in ICU, lenght of hospitalisation, duration of mechanical ventilation /sedation and the existence of PTSD (PCLS) or anxiety/ depression (HADS) will be evaluated and their influence on the completion of AD 1 year
Secondary Evaluation of the privileged interlocutor to discuss AD The privileged interlocutor to discuss AD will be observed 1 year
Secondary Evaluation of the privileged interlocutor to complete AD The privileged interlocutor to complete AD will be observed 1 year
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