Critical IllnessNCT06027684
Intensive Care Decision-making, Survival and Dying Well
An observational study of Critical Illness, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The goal of this study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept intensive care treatment at different chances of survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult (over the age of 18) participants who have experience as a patient on an intensive care/critical care unit will be recruited in this study.
Who may be able to join
- The principle inclusion criteria are being 18 years or older and having previously been a patient on an intensive care/critical care unit in the past.
- Being willing to talk about experiences of intensive care treatment, end-of-life wishes, and the context (chances of survival/functional decline) which would make intensive care treatments acceptable and being willing to either meet in person or have access to a computer, tablet or mobile phone with video and a stable internet connection (for a Zoom conversation) are also inclusion criteria.
Who cannot join
- The exclusion criteria are being under the age of 18, having had a planned admission to an intensive care/critical care unit (e.g. after an elective operation), being unable to consent to participate in the research and having a significant language barrier (as there is no available funding to pay for translation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Manchester
Manchester, M13 9PL
Thomas M Donaldson, MBBChir, 07737298024, thomas.donaldson-2@postgrad.manchester.ac.uk
Soren Holm, 01612753588, soren.holm@manchester.ac.uk
About this study
Official title: Intensive Care Decision-making, Survival and Dying Well: How do the Experiences of Intensive Care Patients and Their End-of-life Wishes Affect Their Willingness to Accept Intensive Care Treatment at Different Chances of Survival?
The goal of this study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept intensive care treatment at different chances of survival.
The main questions it aims to answer are:
Read more
- What can ICU survivors' experiences of ICU treatment tell us about what it would be like to die whilst receiving ICU treatment?
- How do ICU survivors' reflections about what it might be like to die on ICU relate to their own preferences for their end-of-life care?
- What chance of survival would make ICU survivors willing to go through ICU treatment again, in light of the fact that the alternative chance is dying whilst experiencing ICU treatment?
- How does the possibility of reduction in health-related quality of life and functional decline as a result of critical illness impact ICU survivors' willingness to accept ICU treatment again?
Participating in this study will involve filling out a questionnaire and then taking part in an interview. Participants will be recruited through ICU review clinics and ICU steps groups. The study will last for two years and will be conducted at locations convenient to the participants or via zoom.
Read the detailed description
The ageing population of many countries has led to more elderly and increasingly co-morbid patients accessing healthcare services, and intensive care is no exception. This creates an increasing demand for intensive care treatment for patients with a low chance of surviving their critical illness, even with intensive care treatment.
A sedated intensive care patient receiving mechanical ventilation may have the appearance of being unconscious, but follow-up studies with survivors show that many patients have memories of their experiences, which have been described as frightening and chaotic, leading to feelings of instability, vulnerability and fear. Studies have reported recall of pain, disturbing dreams, procedures, thirst, noise, difficulty communicating, difficulty swallowing, awareness of invasive tubes, panic/fear, helplessness, lack of control, feeling tense and patients thinking they were dying. In one study, 67% of patients had recollections of stressful experiences whilst receiving intensive care treatment and 66-92% of these experiences were rated as moderately to extremely distressing. It must be assumed that all intensive care patients (survivors and non-survivors) have similar experiences of their treatment. Therefore, the negative experiences described by survivors must be assumed to be shared by patients who die whilst receiving such treatment. Consequently, dying whilst receiving intensive care treatment is likely to be a significantly distressing experience.
Intensive care treatment may not be beneficial for patients with a low chance of surviving critical illness if the treatment has a high chance of exposing them to a negative dying experience. For intensive care treatment to be ethically justifiable it should offer patients a reasonable chance of survival to justify the burdens inherent in the treatment, and the risks of a negative dying experience. Therefore, a key question in the provision of intensive care treatment is at what chance of survival is this treatment ethically justifiable? An adequate answer to this question will require consideration of both the quantitative benefits of the treatment, such as survival, and the qualitative harms, including suffering and the risk of exposure to a negative dying experience.
Even though dying whilst receiving intensive care treatment is likely to be a negative dying experience, it is not possible to ask patients who did not survive their critical illness about their dying experience or whether they retrospectively agree with the decision to provide them with intensive care treatment. However, all intensive care patients (survivors and non-survivors) have experiences of what it is like to receive intensive care treatment. All ICU patients can be considered a population whose experiences can be represented by the survivors of ICU. Therefore, the experiences described by survivors can provide a window into the experience of patients who die whilst receiving such treatment.
Research to establish the harm-to-benefit ratio that most people would be willing to accept with regards to intensive care treatment is, therefore, of great importance to guide ethical decision-making regarding the provision of intensive care treatment. Of particular importance will be elderly and co-morbid patients' evaluations of their negative intensive care experiences, as these patients are likely to be the ones with the lowest chance of surviving a critical illness. This information could be used to guide intensive care decision-making and to better inform patients of the harms of intensive care treatment. Such research could provide guidance regarding what chance of survival makes the suffering involved in intensive care treatment, acceptable to patients and ensure that intensive care treatment is not routinely offered to patients with a very low chance of surviving their critical illness, for whom the benefit does not outweigh the cost.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The chance of survival that would make participants willing to go through critical care treatment again.
The mixed methods approach will involve triangulation of qualitative and questionnaire data about participants' experiences of intensive care treatment, end-of-life wishes, and the chance of survival that would make them willing to go through critical care treatment again.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start2 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Anaesthetists
- Responsible party
- Principal investigator, Thomas Donaldson, University of Manchester
- Investigators
- Thomas M Donaldson, MB/BChir, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027684
- Sponsor's protocol ID
- NHS002026
- Other IDs
- 317639
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the project, the investigators will deposit a fully anonymised dataset \[e.g., including de-identified interview transcripts\] in an open data repository where it will be permanently stored. The investigators will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. Participants are informed of this in the participant information sheet and will be asked to consent to this on the consent form.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Care Decision-making, Survival and Dying Well: How do the Experiences of Intensive Care Patients and Their End-of-life Wishes Affect Their Willingness to Accept Intensive Care Treatment at Different Chances of Survival?
- ClinicalTrials.gov ID
- NCT06027684
- Acronym / sponsor ID
- NHS002026
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Royal College of Anaesthetists
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Sep 2023 (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 study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept intensive care treatment at different chances of survival.
The main questions it aims to answer are:
- What can ICU survivors' experiences of ICU treatment tell us about what it would be like to die whilst receiving ICU treatment?
- How do ICU survivors' reflections about what it might be like to die on ICU relate to their own preferences for their end-of-life care?
- What chance of survival would make ICU survivors willing to go through ICU treatment again, in light of the fact that the alternative chance is dying whilst experiencing ICU treatment?
- How does the possibility of reduction in health-related quality of life and functional decline as a result of critical illness impact ICU survivors' willingness to accept ICU treatment again?
Participating in this study will involve filling out a questionnaire and then taking part in an interview. Participants will be recruited through ICU review clinics and ICU steps groups. The study will last for two years and will be conducted at locations convenient to the participants or via zoom.
Detailed description
The ageing population of many countries has led to more elderly and increasingly co-morbid patients accessing healthcare services, and intensive care is no exception. This creates an increasing demand for intensive care treatment for patients with a low chance of surviving their critical illness, even with intensive care treatment.
A sedated intensive care patient receiving mechanical ventilation may have the appearance of being unconscious, but follow-up studies with survivors show that many patients have memories of their experiences, which have been described as frightening and chaotic, leading to feelings of instability, vulnerability and fear. Studies have reported recall of pain, disturbing dreams, procedures, thirst, noise, difficulty communicating, difficulty swallowing, awareness of invasive tubes, panic/fear, helplessness, lack of control, feeling tense and patients thinking they were dying. In one study, 67% of patients had recollections of stressful experiences whilst receiving intensive care treatment and 66-92% of these experiences were rated as moderately to extremely distressing. It must be assumed that all intensive care patients (survivors and non-survivors) have similar experiences of their treatment. Therefore, the negative experiences described by survivors must be assumed to be shared by patients who die whilst receiving such treatment. Consequently, dying whilst receiving intensive care treatment is likely to be a significantly distressing experience.
Intensive care treatment may not be beneficial for patients with a low chance of surviving critical illness if the treatment has a high chance of exposing them to a negative dying experience. For intensive care treatment to be ethically justifiable it should offer patients a reasonable chance of survival to justify the burdens inherent in the treatment, and the risks of a negative dying experience. Therefore, a key question in the provision of intensive care treatment is at what chance of survival is this treatment ethically justifiable? An adequate answer to this question will require consideration of both the quantitative benefits of the treatment, such as survival, and the qualitative harms, including suffering and the risk of exposure to a negative dying experience.
Even though dying whilst receiving intensive care treatment is likely to be a negative dying experience, it is not possible to ask patients who did not survive their critical illness about their dying experience or whether they retrospectively agree with the decision to provide them with intensive care treatment. However, all intensive care patients (survivors and non-survivors) have experiences of what it is like to receive intensive care treatment. All ICU patients can be considered a population whose experiences can be represented by the survivors of ICU. Therefore, the experiences described by survivors can provide a window into the experience of patients who die whilst receiving such treatment.
Research to establish the harm-to-benefit ratio that most people would be willing to accept with regards to intensive care treatment is, therefore, of great importance to guide ethical decision-making regarding the provision of intensive care treatment. Of particular importance will be elderly and co-morbid patients' evaluations of their negative intensive care experiences, as these patients are likely to be the ones with the lowest chance of surviving a critical illness. This information could be used to guide intensive care decision-making and to better inform patients of the harms of intensive care treatment. Such research could provide guidance regarding what chance of survival makes the suffering involved in intensive care treatment, acceptable to patients and ensure that intensive care treatment is not routinely offered to patients with a very low chance of surviving their critical illness, for whom the benefit does not outweigh the cost.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (over the age of 18) participants who have experience as a patient on an intensive care/critical care unit will be recruited in this study.
Key inclusion criteria (2 listed)
- The principle inclusion criteria are being 18 years or older and having previously been a patient on an intensive care/critical care unit in the past.
- Being willing to talk about experiences of intensive care treatment, end-of-life wishes, and the context (chances of survival/functional decline) which would make intensive care treatments acceptable and being willing to either meet in person or have access to a computer, tablet or mobile phone with video and a stable internet connection (for a Zoom conversation) are also inclusion criteria.
Key exclusion criteria (1 listed)
- The exclusion criteria are being under the age of 18, having had a planned admission to an intensive care/critical care unit (e.g. after an elective operation), being unable to consent to participate in the research and having a significant language barrier (as there is no available funding to pay for translation).
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
The chance of survival that would make participants willing to go through critical care treatment again.
Time frame: 2 years
The mixed methods approach will involve triangulation of qualitative and questionnaire data about participants' experiences of intensive care treatment, end-of-life wishes, and the chance of survival that would make them willing to go through critical care treatment again.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Yes. At the end of the project, the investigators will deposit a fully anonymised dataset [e.g., including de-identified interview transcripts] in an open data repository where it will be permanently stored. The investigators will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. Participants are informed of this in the participant information sheet and will be asked to consent to this on the consent form.
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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.
Thomas M Donaldson, MB/BChir principal investigator
University of Manchester
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 Critical Illness, run by University of Manchester at 1 site in United Kingdom.
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 1 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: looking for participants now, as of the sponsor's last update on 16 Jan 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas M Donaldson, MB/BChir (07737298024, thomas.donaldson-2@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The chance of survival that would make participants willing to go through critical care treatment again. (time frame: 2 years). 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 16 Jan 2025.