SurgeryPhase 3NCT01486121
Sedation Optimisation Strategy (S.O.S.) Ventilation
A Phase 3 study testing Therapy strategy in people with Surgery and Critical Illness, run by University Hospital, Montpellier at 3 sites in France.
Trial summary
Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Critical Illness, Mechanical Ventilation Complication
- What is being tested?
- Therapy strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2011to Apr 2015
- Phase
- Phase 3
- 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
- Ventilated patient in assist control mode after a surgical procedure expected to be ventilated for 12-hours or more
- At least 1 organ dysfunction according to SOFA score
- Non paralyzed because of neuromuscular blocking agents
- Body temperature > or equal 36°CAge > or equal 18
- Surrogate decision maker's consent
Who cannot join
- Patients without any surgical procedure (medical patients)
- Continuous mechanical ventilation for 24-hours or longer
- Hospitalisation in ICU for 7-days or longer
- Severe ARDS (Acrasis study criteria, New England J Med 2011)
- Neurological injury
- Active toxicomania
Show all 11Show fewer
- Reduction or cessation of active treatment
- Patient under tutelage
- Pregnancy
- No French health insurance
- Enrollment in another study on sedation or mechanical ventilation
Trial locations and contacts
3 sites in 1 country.
France3 sites
Department of Anesthesiology & Critical Care, Estaing University Hospital
Clermont-Ferrand, 63000
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, 34000
Department of Anesthesiology & Critical Care, Caremeau University Hospita
Nîmes, 30000
About this study
Official title: S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients
Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.
Read the detailed description
Intervention group:
- Continuous use of sedatives and analgesics (commonly called "sedation") will be stopped upon enrolment.
- Ventilator asynchrony in Volume assist Controlled Ventilation (VCV) will be treated by switching to Pressure Support Ventilation (PSV) or adjusting setting of VCV.
- Pain, anxiety and agitation will be treated by priority setting of the mechanical ventilator aimed to deliver the most comfortable ventilator support and secondly by adding analgesics and/or psychoactive drugs without inducing a coma state.- Persistent ventilator asynchrony or persistent agitation will be treated by 6-hours continuous sedation periods.
- Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.
Control group (standard practices):
- Continuous use of sedatives and analgesics (commonly called "sedation") will be daily stopped according to criteria defined by the national consensus on sedation for ICU patients.- During the period before the interruption of sedation, ventilator asynchrony in VCV will be treated by increasing the depth of sedation and then the dose of opioids.
- During the period before the interruption of sedation, pain, anxiety and agitation will be treated by a priority adjustment of sedation according to the nurse driven protocol recommended by the national consensus on sedation for ICU patients.- During the period after the interruption of sedation, ventilator asynchrony will be treated by switching to the PSV mode. In case of return to VCV, asynchrony will be treated by restart of sedation.
- During the period after the interruption of sedation, pain, anxiety and agitation will be treated as for the intervention group.
- Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.
- Conditions
- Surgery, Critical Illness, Mechanical Ventilation Complication, Organ Dysfunction Syndrome, Intensive Care Unit Syndrome
- Being tested
- Therapy strategy
- Keywords
- Surgery, Critical illness, Mechanical ventilation, Organ dysfunction syndrome, Intensive Care Units Sedation, Analgesia, Treatment protocol, Nursing protocol, Outcome, Pain, Neurological disorders, Delirium, Muscular weakness, Psychological disorders, Anxiety, Depression, Stress disorders, Post-Traumatic
- Medical subject headings
- Critical Illness, Agnosia, Pain, Nervous System Diseases, Delirium, Muscle Weakness, Mental Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy strategyOther
Sedation \& mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| S.O.S.-V | Other | Not described Receives: Other: Therapy strategy |
| Standard | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful intubation
Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours.
Measured: for 48 hours after intubation
Secondary outcomes (7)
Dose and duration of sedation
Dose and duration of sedation
Measured: Day 0 to Days 28
Type and duration of mechanical ventilation
Type and duration of mechanical ventilation
Measured: Day 0 to Days 28
Complications acquired in ICU
Complications acquired in ICU stress ulcers ileus infections delirium neuromuscular weakness pain
Measured: Days 28
Length of stay in ICU and hospital
Length of stay in ICU and hospital
Measured: up to 6 months
Mortality
ICU mortality, 3 months mortality and 12 months mortality
Measured: up to 12 months
Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge
Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge
Measured: up to 6 months
Incidence and duration of organ dysfunctions
Incidence and duration of organ dysfunctions
Measured: Day 1 to Days 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2015
- Study completionApr 2015
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 SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald GC Chanques, MD, PhD, Principal investigator, UH, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486121
- Sponsor's protocol ID
- 8667
- Status last verified
- Dec 2015
- First submitted
- 10 Nov 2011
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cisse M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.
PubMed 28935558
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S.O.S. Ventilation - Sedation Optimisation Strategy For Mechanical Ventilation In Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01486121
- Acronym / sponsor ID
- 8667
- Conditions
- Surgery, Critical Illness, Mechanical Ventilation Complication, Organ Dysfunction Syndrome, Intensive Care Unit Syndrome
- Keywords
- Surgery, Critical illness, Mechanical ventilation, Organ dysfunction syndrome, Intensive Care Units Sedation, Analgesia, Treatment protocol, Nursing protocol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Dec 2011 (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.
Use of sedatives and analgesics is common in mechanically ventilated patients hospitalized in Intensive Care Unit (ICU). That is called " sedation " and aimed to reduce both pain and anxiety and also to allow an effective and atraumatic mechanical ventilation. However, sedation excess and ventilator support excess, both in duration and intensity, are associated with an excess morbidity. Patients usually are systematically sedated after having been intubated. Then, sedation is stopped first before ventilator support is weaning. Several studies shown that rationalized protocols of sedation and ventilation orderings had a beneficial impact on non surgical patients' outcome. Feasibility of these protocols in surgical patients is still unknown. Moreover, no study has evaluated an optimized paired strategy of sedation-ventilation based on the priority setting of ventilation. This priority setting of ventilation should increase patient's comfort in spite of increasing sedatives and analgesics dosing. An paired sedation-ventilation protocol optimized for both duration and intensity of these treatments could improve surgical patients' outcome in ICU.
Detailed description
Intervention group:
- Continuous use of sedatives and analgesics (commonly called "sedation") will be stopped upon enrolment.
- Ventilator asynchrony in Volume assist Controlled Ventilation (VCV) will be treated by switching to Pressure Support Ventilation (PSV) or adjusting setting of VCV.
- Pain, anxiety and agitation will be treated by priority setting of the mechanical ventilator aimed to deliver the most comfortable ventilator support and secondly by adding analgesics and/or psychoactive drugs without inducing a coma state.- Persistent ventilator asynchrony or persistent agitation will be treated by 6-hours continuous sedation periods.
- Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.
Control group (standard practices):
- Continuous use of sedatives and analgesics (commonly called "sedation") will be daily stopped according to criteria defined by the national consensus on sedation for ICU patients.- During the period before the interruption of sedation, ventilator asynchrony in VCV will be treated by increasing the depth of sedation and then the dose of opioids.
- During the period before the interruption of sedation, pain, anxiety and agitation will be treated by a priority adjustment of sedation according to the nurse driven protocol recommended by the national consensus on sedation for ICU patients.- During the period after the interruption of sedation, ventilator asynchrony will be treated by switching to the PSV mode. In case of return to VCV, asynchrony will be treated by restart of sedation.
- During the period after the interruption of sedation, pain, anxiety and agitation will be treated as for the intervention group.
- Extubation will be performed according to criteria defined by the national consensus on mechanical ventilation weaning, which are based on a daily spontaneous breathing trial in the absence of any sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S.O.S.-V | Other | Other: Therapy strategy |
| Standard | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ventilated patient in assist control mode after a surgical procedure expected to be ventilated for 12-hours or more
- At least 1 organ dysfunction according to SOFA score
- Non paralyzed because of neuromuscular blocking agents
- Body temperature > or equal 36°CAge > or equal 18
- Surrogate decision maker's consent
Key exclusion criteria (11 listed)
- Patients without any surgical procedure (medical patients)
- Continuous mechanical ventilation for 24-hours or longer
- Hospitalisation in ICU for 7-days or longer
- Severe ARDS (Acrasis study criteria, New England J Med 2011)
- Neurological injury
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 |
|---|---|---|
| Therapy strategySedation \& mechanical ventilation | Other | S.O.S.-V |
Primary outcome
Time to successful intubation
Time frame: for 48 hours after intubation
Time to successful intubation is defined as time from randomization to extubation (or tracheotomy mask) for 48 hours.
7 secondary outcomes
Dose and duration of sedation
Time frame: Day 0 to Days 28
Type and duration of mechanical ventilation
Time frame: Day 0 to Days 28
Complications acquired in ICU
Time frame: Days 28
Length of stay in ICU and hospital
Time frame: up to 6 months
Mortality
Time frame: up to 12 months
Quality of life, anxiety, depression, post-traumatic stress disorder 3 and 12 months after ICU discharge
Time frame: up to 6 months
Incidence and duration of organ dysfunctions
Time frame: Day 1 to Days 5
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 Dec 2015.
- Derived from this study: PubMed 28935558Chanques G, Conseil M, Roger C, Constantin JM, Prades A, Carr J, Muller L, Jung B, Belafia F, Cisse M, Delay JM, de Jong A, Lefrant JY, Futier E, Mercier G, Molinari N, Jaber S; SOS-Ventilation study investigators. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial. Lancet Respir Med. 2017 Oct;5(10):795-805. doi: 10.1016/S2213-2600(17)30304-1. Epub 2017 Sep 18.
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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.
Gerald GC Chanques, MD, PhD principal investigator
UH, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapy strategy in people with Surgery and Critical Illness, run by University Hospital, Montpellier at 3 sites 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 5 inclusion and 11 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to successful intubation (time frame: for 48 hours after intubation). 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 NCT01486121, 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 2 Dec 2015.