Acute Respiratory Distress SyndromePhase 4SEGANCT02166853
Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study)
A Phase 4 study testing sevoflurane and midazolam in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- sevoflurane and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Mar 2016
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with criteria for moderate to severe ARDS since less than 24 hours (
- Informed consent
Who cannot join
- Suspected or proven intracranial hypertension
- Midazolam, sevoflurane or cisatracurium allergy
- Medical history of malignant hyperthermia
- Severe liver failure
- Chemotherapy treatment in the last month
- Severe neutropenia (< 0.5 G/l)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early 48-hour Sevoflurane Inhalation on Gas Exchange and Inflammation in Patients Presenting With Acute Respiratory Distress Syndrome (ARDS) : a Monocentric, Prospective, Randomized Study.
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.
Read the detailed description
BACKGROUND:
Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar fluid clairance impairment.
Several preclinical studies have shown that early sevoflurane inhalation improves gas exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in experimental models of ARDS.
To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS patients.
DESIGN NARRATIVE:
The purpose of this prospective, randomized, controlled study is to evaluate the effects of a 48-hour sevoflurane inhalation strategy on gas exchange and both systemic and pulmonary inflammation in the early phase of ARDS.
After inclusion, ICU patients with moderate to severe ARDS (according to the Berlin definition of ARDS criteria; JAMA 2010) will be randomized into two groups :
- a "conventional group", in which intravenous sedation with midazolam will be administered
- a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices Arterial blood gases will be analyze before randomization and at 24, 48, 72, 96, and 120 hours.
Bronchoalveolar lavages (BAL) and blood samples will be assessed before randomization and at 48 hours, in order to measure tumor necrosis factor-alpha (TNFα), interleukin (IL)-1β, IL-6, IL-8 and sRAGE levels. Duplicate assays will be performed with Multiplex (TNFα/interleukins) or ELISA (sRAGE).
During the 48-hour treatment period, bispectral index (BIS®) values ranging from 40 to 50 will be targeted and neuromuscular blocking agents (cisatracurium) will be administered in both groups. Protective ventilation strategies will be applied, as well as other guidelines or recommendations on the management of ICU patients with ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- sevoflurane, midazolam
- Keywords
- Acute respiratory distress syndrome (ARDS), Sevoflurane, Mechanical ventilation, Intensive Care Unit (ICU), Prospective study, Lung injury, Gas exchange, Inflammation, Receptor for advanced glycation end-produts (RAGE), sRAGE
- Medical subject headings
- Respiratory Distress Syndrome, Lung Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
Sedation with inhaled sevoflurane
midazolamDrug
Sedation with intravenous midazolam
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Experimental | a "conventional group", in which intravenous sedation with midazolam will be administered Receives: Drug: midazolam |
| sevoflurane group | Experimental | a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
Measured: at 48 hours
Secondary outcomes (12)
- Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8
Measured: at 48 hours
Plasma and alveolar levels of sRAGE
Measured: at 48 hours
PaO2/FiO2 ratio
Measured: at day 1, day 3, day 5
Lowest PaO2/FiO2 during the first 5 days of the study
Measured: at 5 days
Mean PaO2/FiO2 ratio during the first 5 days of the study
Measured: at 5 days
Pulmonary static compliance, resistance and elastance
Measured: at day 1, day 2
Duration of controlled mechanical ventilation
Measured: at day 30
Total duration of mechanical ventilation (controlled/assisted)
Measured: at day 30
Number of ventilatory-free days
Measured: at day 30
Number of organ failure-free days
Measured: at day 30
Vasopressor requirements
Measured: at 48 hours
Mortality
Measured: at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionMar 2016
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 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu JABAUDON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166853
- Sponsor's protocol ID
- CHU-0195
- Other IDs
- 2013-005389-21
- Acronym
- SEGA
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
Publications
Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.
PubMed 27611637
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early 48-hour Sevoflurane Inhalation on Gas Exchange and Inflammation in Patients Presenting With Acute Respiratory Distress Syndrome (ARDS) : a Monocentric, Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT02166853
- Acronym / sponsor ID
- SEGA / CHU-0195
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome (ARDS), Sevoflurane, Mechanical ventilation, Intensive Care Unit (ICU), Prospective study, Lung injury, Gas exchange, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Jun 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.
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.
Detailed description
BACKGROUND:
Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar fluid clairance impairment.
Several preclinical studies have shown that early sevoflurane inhalation improves gas exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in experimental models of ARDS.
To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS patients.
DESIGN NARRATIVE:
The purpose of this prospective, randomized, controlled study is to evaluate the effects of a 48-hour sevoflurane inhalation strategy on gas exchange and both systemic and pulmonary inflammation in the early phase of ARDS.
After inclusion, ICU patients with moderate to severe ARDS (according to the Berlin definition of ARDS criteria; JAMA 2010) will be randomized into two groups :
- a "conventional group", in which intravenous sedation with midazolam will be administered
- a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices Arterial blood gases will be analyze before randomization and at 24, 48, 72, 96, and 120 hours.
Bronchoalveolar lavages (BAL) and blood samples will be assessed before randomization and at 48 hours, in order to measure tumor necrosis factor-alpha (TNFα), interleukin (IL)-1β, IL-6, IL-8 and sRAGE levels. Duplicate assays will be performed with Multiplex (TNFα/interleukins) or ELISA (sRAGE).
During the 48-hour treatment period, bispectral index (BIS®) values ranging from 40 to 50 will be targeted and neuromuscular blocking agents (cisatracurium) will be administered in both groups. Protective ventilation strategies will be applied, as well as other guidelines or recommendations on the management of ICU patients with ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Experimental | Drug: midazolama "conventional group", in which intravenous sedation with midazolam will be administered |
| sevoflurane group | Experimental | Drug: sevofluranea "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with criteria for moderate to severe ARDS since less than 24 hours (
- Informed consent
Key exclusion criteria (6 listed)
- Suspected or proven intracranial hypertension
- Midazolam, sevoflurane or cisatracurium allergy
- Medical history of malignant hyperthermia
- Severe liver failure
- Chemotherapy treatment in the last month
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 |
|---|---|---|
| sevofluraneSedation with inhaled sevoflurane | Drug | sevoflurane group |
| midazolamSedation with intravenous midazolam | Drug | conventional group |
Primary outcome
PaO2/FiO2 ratio
Time frame: at 48 hours
12 secondary outcomes
- Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8
Time frame: at 48 hours
Plasma and alveolar levels of sRAGE
Time frame: at 48 hours
PaO2/FiO2 ratio
Time frame: at day 1, day 3, day 5
Lowest PaO2/FiO2 during the first 5 days of the study
Time frame: at 5 days
Mean PaO2/FiO2 ratio during the first 5 days of the study
Time frame: at 5 days
Pulmonary static compliance, resistance and elastance
Time frame: at day 1, day 2
Duration of controlled mechanical ventilation
Time frame: at day 30
Total duration of mechanical ventilation (controlled/assisted)
Time frame: at day 30
Number of ventilatory-free days
Time frame: at day 30
Number of organ failure-free days
Time frame: at day 30
Vasopressor requirements
Time frame: at 48 hours
Mortality
Time frame: at day 30
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 21 Apr 2026.
- Results publication: PubMed 27611637Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.
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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.
Matthieu JABAUDON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevoflurane and midazolam in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand 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 6 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 21 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
PaO2/FiO2 ratio (time frame: at 48 hours). 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 NCT02166853, 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 21 Apr 2026.