Stress Disorders, Post-TraumaticNCT02040649
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on PTSD
A study testing Non-sedation in people with Stress Disorders, Post-Traumatic and Depression, run by Palle Toft at 1 site in Denmark.
Trial summary
Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- What is being tested?
- Non-sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Mar 2019
- Phase
- Interventional
- 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
Who may be able to join
- Endotracheally intubated
- Expected time on ventilator > 24 hours
- Age ≥ 18 years
- Informed consent
Who cannot join
- Severe head trauma where therapeutic coma is indicated
- Therapeutic hypothermia where therapeutic coma is indicated
- Status epilepticus where therapeutic coma is indicated
- Patient has participated in the study before
- Patient is transferred from another ICU with length of stay > 48 hours
- Patient is comatose at admission
- PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation
- Patient does not speak Danish, swedish or norwegian at a reasonable level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substudy of the NONSEDA-trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Posttraumatic Stress Disorder
Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.
Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.
- Conditions
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- Being tested
- Non-sedation, Control, sedation (propofol, midazolam)
- Keywords
- Critical care, Respiration, artificial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-sedationOther
Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
Control, sedation (propofol, midazolam)Other
Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.
| Study group | Role | What they receive |
|---|---|---|
| Non-sedation | Experimental | Non-sedation supplemented with pain management during mechanical ventilation. Receives: Other: Non-sedation |
| Sedation | Active comparator | Current gold standard: Sedation with a daily wake-up trial. Receives: Other: Control, sedation (propofol, midazolam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria.
Measured: 3 months after discharge from ICU
Secondary outcomes (3)
Patient-reported quality of life
SF-36v2, mental component score for each group. The questionnaire is mailed to the participants, who complete it at home.
Measured: 3 months after discharge from ICU
Depression
Number of patients in each group diagnosed with depresion by the neuropsycologist, based on personal interview and Beck depression inventory score.
Measured: 3 months after discharge from ICU
Anxiety
Number of patients in each group diagnosed with anxiety by the neuropsycologist, based on personal interveiw and Beck anxiety inventory score.
Measured: 3 months after discarge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2017
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palle Toft
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, The Danish Council for Strategic Research, University of Southern Denmark
- Responsible party
- Sponsor-investigator, Palle Toft, Odense University Hospital
- Investigators
- Helene Nedergaard, MD, Principal investigator, Lillebaelt Hospital, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040649
- Sponsor's protocol ID
- S-20130025b
- Status last verified
- Mar 2019
- First submitted
- 10 Jan 2014
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
PubMed 22166673
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy of the NONSEDA-trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02040649
- Acronym / sponsor ID
- S-20130025b
- Conditions
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- Keywords
- Critical care, Respiration, artificial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Palle ToftUniversity, hospital or other
- Collaborators
- Kolding Sygehus, The Danish Council for Strategic Research, University of Southern Denmark
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from ICU.
Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-sedation | Experimental | Other: Non-sedationNon-sedation supplemented with pain management during mechanical ventilation. |
| Sedation | Active comparator | Other: Control, sedation (propofol, midazolam)Current gold standard: Sedation with a daily wake-up trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Endotracheally intubated
- Expected time on ventilator > 24 hours
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (8 listed)
- Severe head trauma where therapeutic coma is indicated
- Therapeutic hypothermia where therapeutic coma is indicated
- Status epilepticus where therapeutic coma is indicated
- Patient has participated in the study before
- Patient is transferred from another ICU with length of stay > 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-sedationPatients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv. | Other | Non-sedation |
| Control, sedation (propofol, midazolam)Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake. | Other | Sedation |
Primary outcome
PTSD
Time frame: 3 months after discharge from ICU
Number of patients in each group diagnosed with PTSD by a neuropsycologist, based on an interview including posttraumatic stress disorder index and a general evaluation of the patient based on the ICD-10 criteria.
3 secondary outcomes
Patient-reported quality of life
Time frame: 3 months after discharge from ICU
Depression
Time frame: 3 months after discharge from ICU
Anxiety
Time frame: 3 months after discarge from ICU
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 15 Mar 2019.
- Background: PubMed 22166673Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
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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.
Helene Nedergaard, MD principal investigator
Lillebaelt Hospital, Kolding
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-sedation in people with Stress Disorders, Post-Traumatic and Depression, run by Palle Toft at 1 site in Denmark.
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 4 inclusion and 8 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 15 Mar 2019. 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 Denmark. 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?
PTSD (time frame: 3 months after discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040649, which also lists 1 linked publication.
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 15 Mar 2019.