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.
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
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.
- Conditions
- Quality of Life, Post ICU Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Defining a threshold value for the IPREA score
Evaluation of IPREA score
Measured: through study completion, an average of 1 year
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
Establish a correlation between IPREA score and time to first rise
Evaluation of IPREA score
Measured: through study completion, an average of 1 year
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.
- First posted2 Feb 2024
- Study start8 Sep 2022
- Primary completion14 Oct 2023
- Study completion14 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Romain Ronfle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Romain Ronfle, Centre Hospitalier Intercommunal Aix-Pertuis
- Investigators
- Romain RONFLE, MD, Principal investigator, Centre Hospitalier Intercommunal Aix-Pertuis
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
- ClinicalTrials.gov ID
- NCT06238557
- Acronym / sponsor ID
- PICS / 20220205-7
- Conditions
- Quality of Life, Post ICU Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Romain RonfleUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 14 Oct 2023 (actual)
- Study completion
- 14 Oct 2023 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU during minimum 3 days
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Occurrence of discomfort in intensive care as defined by the IPREA score
6 secondary outcomes
Assessing the value of the IPREA score in terms of quality of life at 3 months
Time frame: 3 months
Identifying the 3 areas of discomfort most associated with progression to post ICU syndrome at 3 months
Time frame: 3 months
Defining a threshold value for the IPREA score
Time frame: through study completion, an average of 1 year
Correlation between clinical assessment and psychological follow-up with the post ICU syndrome
Time frame: through study completion, an average of 1 year
Establish a correlation between IPREA score and time to first rise
Time frame: through study completion, an average of 1 year
Correlation between identified factors of post ICU syndrome and IPREA score
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain RONFLE, MD principal investigator
Centre Hospitalier Intercommunal Aix-Pertuis
1 site in 1 country: see every site and its status.
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.