Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06238557 |
| Other study ID # |
20220205-7 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2022 |
| Est. completion date |
October 14, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Centre Hospitalier Intercommunal Aix-Pertuis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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
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.
