Critically IllNCT02034942
Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function
A study testing Non-sedation in people with Critically Ill and Muscular Atrophy, run by Palle Toft at 1 site in Denmark.
Trial summary
Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Muscular Atrophy
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substudy of Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength.
Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU.
Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.
- Conditions
- Critically Ill, Muscular Atrophy
- Being tested
- Non-sedation, Sedation, control
- Keywords
- non-sedation
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-sedationOther
Sedation, controlOther
Also called Standard treatment, continuous iv-sedation
| Study group | Role | What they receive |
|---|---|---|
| Non-sedation | Experimental | The experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive.
Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol. Receives: Other: Non-sedation |
| Sedation with daily wake-up | Active comparator | The control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks:
* Open the eyes to verbal commands.
* Follow the examiner's instructions with the eyes.
* Squeeze hands on request.
* Stick out the tongue on request.
After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4. Receives: Other: Sedation, control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index.
Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025.
Measured: 3 months after ICU-discharge
Secondary outcomes (4)
6 minute walk
Walking distance in the 6 minute walk test at 3 months follow-up
Measured: 3 months after ICU-discharge
Handgrip
Handgrip-strength at 3 month follow-up
Measured: 3 months after ICU-discharge
Thigh muscle size
Muscle size, measured as cross section area of the rectus femoris muscle at 3 months follow-up
Measured: 3 months after ICU-discharge
Biomechanical data
Muscle strength, measured using biomechanical measurements - Maximal voluntary contraction (MVC), rate of force developement (RFD) and endurance at 25% of MVC at 3 months follow-up
Measured: 3 months after ICU-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 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 (3)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palle Toft
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt, University of Southern Denmark, The Danish Council for Strategic Research
- Responsible party
- Sponsor-investigator, Palle Toft, Odense University Hospital
- Investigators
- Helene K Nedergaard, MD, Principal investigator, Lillebaelt Hospital, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034942
- Sponsor's protocol ID
- S-20130025a
- Status last verified
- Mar 2019
- First submitted
- 9 Jan 2014
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
PubMed 20116842Nedergaard HK, Jensen HI, Olsen HT, Strom T, Lauridsen JT, Sjogaard G, Toft P. Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial. J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.
PubMed 33276294Nedergaard HK, Jensen HI, Lauridsen JT, Sjogaard G, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
PubMed 26201718
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 Non-Seda Trial (NCT01967680): Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation - Effects on Physical Function. An Investigator-initiated, Randomised, Clinical, Parallel-group, Multinational, Superiority Trial
- ClinicalTrials.gov ID
- NCT02034942
- Acronym / sponsor ID
- S-20130025a
- Conditions
- Critically Ill, Muscular Atrophy
- Keywords
- non-sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Palle ToftUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt, University of Southern Denmark, The Danish Council for Strategic Research
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 14 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.
Critically ill, ventilator-treated patients rapidly loose much of their muscle mass and strength. This can attribute to prolonged admission, prolonged mechanical ventilation, increased mortality and might have a negative impact on the physical function, degree of independence and quality of life. The pathophysiological background for the loss of muscle mass as well as possible effective treatment is still not well established. In the NONSEDA-trial we randomise critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit (ICU). It has never been assessed whether non-sedation reduces the loss of muscle mass and strength.
Aim: To assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from ICU.
Hypothesis: that non-sedation during ventilator-treatment will improve the physical function after ICU-discharge, compared with standard treatment of sedation with a daily wake-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-sedation | Experimental | Other: Non-sedationThe experimental group will not receive sedatives. Patients are thoroughly and repeatedly informed by the staff of where they are, what have happened, and what type of treatment they are going to receive. Participants will be awake and have a natural sleep rhythm. In case these patients develop and outward delirium, it is necessary to have a nurse or other caregiver at the bedside in order to calm the patient. Patients with delirium will be treated with haloperidol. |
| Sedation with daily wake-up | Active comparator | Other: Sedation, controlThe control group will be sedated to Ramsay score 3-4. The first 48 hours the patients will be sedated with propofol, after 48 hours midazolam will be used. During daytime, the patient will be awakened as the intravenous infusion of sedatives will be discontinued. The patient will be considered to be awake when he/she can perform at least three of the following four tasks: * Open the eyes to verbal commands. * Follow the examiner's instructions with the eyes. * Squeeze hands on request. * Stick out the tongue on request. After a successful wake-up, the infusion of sedative will be resumed, starting on half of the pre-wake-up dose and adjusted to Ramsey score 3-4. |
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 (7 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-sedation | Other | Non-sedation |
| Sedation, controlAlso: Standard treatment, continuous iv-sedation | Other | Sedation with daily wake-up |
Primary outcome
Physical function
Time frame: 3 months after ICU-discharge
Co-primary outcome of: patient-reported quality of life, as measured by SF-36v2, physical component and degree of independence in activities of daily living, as measured by Barthel Index. Since this is a co-primary outcome, the type I error probability associated with the test of the null hypothesis should be less than 0,025.
4 secondary outcomes
6 minute walk
Time frame: 3 months after ICU-discharge
Handgrip
Time frame: 3 months after ICU-discharge
Thigh muscle size
Time frame: 3 months after ICU-discharge
Biomechanical data
Time frame: 3 months after ICU-discharge
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 20116842Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
- Derived from this study: PubMed 33276294Nedergaard HK, Jensen HI, Olsen HT, Strom T, Lauridsen JT, Sjogaard G, Toft P. Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial. J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.
- Derived from this study: PubMed 26201718Nedergaard HK, Jensen HI, Lauridsen JT, Sjogaard G, Toft P. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
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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 K 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 Critically Ill and Muscular Atrophy, 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 7 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?
Physical function (time frame: 3 months after ICU-discharge). 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 NCT02034942, which also lists 3 linked publications.
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.