AzTrials
AzTrials

Quality of LifePICSNCT06238557

Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life

An observational study of Quality of Life and Post ICU Syndrome, run by Romain Ronfle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this observational study is to show the patient discomfort during their stay in intensive care is directly linked to the occurrence of a post ICU syndrome at 3 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Quality of Life, Post ICU Syndrome
How many people
175 participants
Where
1 siteFrance
Study dates
8 Sep 2022to 14 Oct 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted in ICU during minimum 3 days

Who may be able to join

  • Patient admitted to the intensive care unit at Aix-en-Provence hospital (sepsis, acute respiratory distress, disturbed consciousness, emergency surgery, etc.)
  • Minimum stay of 3 calendar days

Who cannot join

  • Patient under 18 years
  • Patients deprived of their liberty, under guardianship or trusteeship
  • Non-French-speaking patient
  • Presence of a pre-existing cognitive disorder as assessed by a clinician
  • Participation in an interventional research protocol

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Intercommunal Aix-Pertuis

    Aix-en-Provence, 13100

Other trials in France

About this study

The goal of this observational study is to show the patient discomfort during their stay in intensive care is directly linked to the occurrence of a post ICU syndrome at 3 months.

The main questions it aims to answer are :

  • Evaluate the value of the IPREA score on quality of life impairment a 3 months ;
  • Identify the 3 areas of discomfort most associated with progression to a post ICU syndrome at 3 months ;
  • Define a threshold value for the IPREA score ;
  • Correlate clinical assessment and psychological follow-up with the to the prediction of a post ICU syndrome ;
  • Establish a correlation between IPREA score and time to first rise
  • Establish a correlation between identified factors of post ICU syndrome and IPREA score
Read the detailed description

A stay in intensive care can be seen as a stressful ordeal for a patient's body, both physically and morally. Among patients alive following a stay in intensive care, half have a disabling psychiatric disorder. The main psychiatric disorders described in post-resuscitation are anxiety, depression and post-traumatic stress disorder (PTSD). When one of these disorders is present, there is a 64% chance that it will coexist with one of the other two disorders. These psychological disorders will have an impact on the quality of life and mortality of patients leaving intensive care. Depression is independently associated with an increased risk of further hospitalisation. These different psychological and somatic disorders can be found in the same entity: post-resuscitation syndrome (PRS).

In a context where the proportion of awake patients is growing in our intensive care units, the impact of subjective factors is becoming increasingly important. A stay in intensive care is marked by a stressful environment for the patient at several levels, as well as by care procedures that are often experienced as traumatic (mechanical ventilation, dialysis and invasive procedures). For example, memories of terrifying experiences, often the source of nightmares or hallucinations that persist beyond the hospital stay, encourage the development of PTSD. Similarly, certain environmental factors such as lighting conditions and noise levels can have an impact on patient comfort during their stay in intensive care, confirming the importance of better controlling all external factors that can contribute to stress. Targeted measures centred on an isolated objective, such as reducing thirst, have shown real clinical benefit in terms of patient outcome. Recognition of these sources of discomfort in intensive care and resuscitation units is a first step towards optimising patient comfort. A research team have developed a standardised and validated discomfort score (Discomforts of Patients in Intensive Care, IPREA) that enables several discomforts perceived throughout the intensive care stay to be identified and quantified.

In addition to the psychiatric consequences, the investigators know that patients who survive a stay in intensive care face physical and cognitive consequences for their state of health. PRS is a concept that includes these three dimensions, defined as cognitive dysfunction, acquired physical weakness and altered mental health. It is thought to affect at least 50% of patients. The growing interest in this syndrome is explained by its multi-dimensional aspect, which is representative of patients' long-term quality of life. The potential impact between discomfort in intensive care and long-term psychiatric consequences, or more broadly the occurrence of an PRS, is a central question with an impact on our daily practice. In addition, a bedside assessment using simple tools as part of a psychological follow-up could help to prevent or at least recognise early the factors favouring an PRS.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing the impact of the overall discomfort of intensive care patients on the occurrence of a psychiatric RPD at 3 months

    Occurrence of discomfort in intensive care as defined by the IPREA score

    Measured: 3 months

Secondary outcomes (6)
  1. Assessing the value of the IPREA score in terms of quality of life at 3 months

    Relation between IPREA score and quality of life

    Measured: 3 months

  2. Identifying the 3 areas of discomfort most associated with progression to post ICU syndrome at 3 months

    Relation between discomfort during hospitalization and post ICU syndrome

    Measured: 3 months

  3. Defining a threshold value for the IPREA score

    Evaluation of IPREA score

    Measured: through study completion, an average of 1 year

  4. Correlation between clinical assessment and psychological follow-up with the post ICU syndrome

    Clinical experience of the clinician and the psychologist and the interest in predicting a post ICU syndrome

    Measured: through study completion, an average of 1 year

  5. Establish a correlation between IPREA score and time to first rise

    Evaluation of IPREA score

    Measured: through study completion, an average of 1 year

  6. Correlation between identified factors of post ICU syndrome and IPREA score

    Evaluation and relation between factors of post ICU syndrome and IPREA score

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start8 Sep 2022
  3. Primary completion14 Oct 2023
  4. Study completion14 Oct 2023

Resources

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
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238557
Sponsor's protocol ID
20220205-7
Acronym
PICS
Status last verified
Jan 2024
First submitted
15 Jan 2024
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Post ICU Syndrome, run by Romain Ronfle 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 2 inclusion and 5 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 2 Feb 2024. 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?

Assessing the impact of the overall discomfort of intensive care patients on the occurrence of a psychiatric RPD at 3 months (time frame: 3 months). 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 2 Feb 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in