Acute Respiratory Distress SyndromeSPIDERMANNCT04023305
Sevoflurane PharmacokInetics in ARDS
A study testing Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 3 sites in France.
Trial summary
The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Feb 2020to 1 Jan 2022
- 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
- Age ≥18 years
- Presence for ≤ 12 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms :
- a PaO2/FiO2 < 200 mmHg with positive end-expiratory pressure (PEEP) ≥ 8 cmH2O (or, if arterial blood gas not available : SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 200 mmHg with PEEP ≥8 cmH2O, and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial SpO2/FiO2 ratio determination) b Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules c Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present
Who cannot join
- Lack of informed consent
- Continuous sedation with inhaled sevoflurane at enrollment
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
- Body mass index > 40 kg/m2
Show all 19Show fewer
- Chronic liver disease defined as a Child-Pugh score of 12-15
- Expected duration of mechanical ventilation < 48 hours
- Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL
- Decision to withhold life-sustaining treatment; except in those patients committed to full support except cardiopulmonary resuscitation
- Moribund patient, i.e. not expected to survive 24 hours despite intensive care
- Burns > 70% total body surface
- Previous hypersensitivity or anaphylactic reaction to sevoflurane
- Medical history of malignant hyperthermia
- Suspected or proven intracranial hypertension
- Know pregnancy - Pregnancy testing will be systematically performed to rule out pregnancy in female patients of reproductive age
- Enrollment in another interventional ARDS trial with direct impact on sedation and PEEP
- Endotracheal ventilation for greater than 120 hours (5 days)
- PaO2/FiO2 (if available) > 200 mmHg after meeting inclusion criteria and before start of the study
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Jean Perrin
Clermont-Ferrand
CHU
Clermont-Ferrand
APHP - University hospital of Saint-Louis
Paris, 75010
About this study
Official title: Sevoflurane pharmacokInetics During Inhaled Sedation Relies on the Morphotype of ARDS in ICU Patients
The main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.
Read the detailed description
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Blood sample will be collected at different times after the onset of sevoflurane administration and after its cessation.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts
- Keywords
- Nonfocal Acute respiratory distress syndrome, Focal Acute respiratory distress syndrome, Sevoflurane, Pharmacokinetics, Mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNtsDrug
Pharmacokinetic of inhaled sevoflurane used for sedation
| Study group | Role | What they receive |
|---|---|---|
| Nonfocal ARDS | Experimental | ARDS patient with nonfocal lung imaging phenotype Receives: Drug: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts |
| Focal ARDS | Experimental | ARDS patient with focal lung imaging phenotype Receives: Drug: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 5 minutes after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 30 minutes after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 1 hour after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 6 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 24 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 48 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 5 minutes after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 30 minutes after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 1 hour after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 4 hours after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Measured: 6 hours after the cessation of sevoflurane administration
Secondary outcomes (7)
Plasma concentration of hexafluoroisopropanolol
Plasma concentration of hexafluoroisopropanolol
Measured: Until sedation can be definitely interrupted or until day 7
Fraction of inspired sevoflurane
Fraction of inspired sevoflurane
Measured: Until sedation can be definitely interrupted or until day 7
Fraction of expired sevoflurane
Fraction of expired sevoflurane
Measured: Until sedation can be definitely interrupted or until day 7
Dose of sevoflurane
Dose of sevoflurane (mg/l)
Measured: Until sedation can be definitely interrupted or until day 7
Infusion duration of sevoflurane
Infusion duration of sevoflurane (min)
Measured: Until sedation can be definitely interrupted or until day 7
Infusion rate of remifentanil
Infusion rate of remifentanil
Measured: Until sedation can be definitely interrupted or until day 7
Values of a bispectral index
Values of a bispectral index
Measured: Until sedation can be definitely interrupted or until day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start23 Feb 2020
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Inhaled sedation with sevoflurane, will be vaporized via the miniaturized Anesthesia Conserving Device (AnaConDa-S®, Sedana Medical, Uppsala, Sweden). Sevoflurane infusion rate will be adapted from manufacturer's instructions in order to reach a target of expired sevoflurane fraction (FEsevo) of 0.8-1.1. Mechanical ventilation will be protocolized in both arms, based on recent results of a RCT from our group, in which 90-day survival was improved in patients with nonfocal ARDS when an individualized ventilation strategy was applied, compared to the ARDSNet strategy (PEEP set according to FiO2). We will recommend sites wait at least 12 hours before proning, as in the PROSEVA study. In both groups, patients will receive cisatracurium besylate for neuromuscular blockade, and deep sedation will be protocolized to Richmond Agitation-Sedation Scale (RASS) of -4 to -5 (Ramsay of 5-6, or Riker of 1-2) before starting, and during, the cisatracurium besylate infusion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raiko Blondonnet, MD, MSc, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023305
- Sponsor's protocol ID
- SPIDERMAN Study
- Other IDs
- 2018-003511-21, 2018
- Acronym
- SPIDERMAN
- Status last verified
- Dec 2023
- First submitted
- 10 Jul 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane pharmacokInetics During Inhaled Sedation Relies on the Morphotype of ARDS in ICU Patients
- ClinicalTrials.gov ID
- NCT04023305
- Acronym / sponsor ID
- SPIDERMAN / SPIDERMAN Study
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Nonfocal Acute respiratory distress syndrome, Focal Acute respiratory distress syndrome, Sevoflurane, Pharmacokinetics, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Jul 2019 (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 main objective of this study is to compare the pharmacokinetic models of sevoflurane-induced sedation during ARDS depending on the lung imaging phenotype (focal vs nonfocal phenotypes) The authors hypothesized that sevoflurane used for inhaled sedation could have distinct pharmacokinetic profiles depending on lung imaging phenotypes (focal vs nonfocal) during ARDS in ICU patients.
Detailed description
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Adult patients admitted to the ICU within 12 hours of moderate-severe ARDS onset and under sedation with sevoflurane will be enrolled in the study with inclusion criteria. They will be enrolled, depending on their morphotype (focal or nonfocal), as routinely assessed in participating centers using CT-scan, chest x-ray and/or lung ultrasound.
These patients will receive inhaled sevoflurane as a standard practice of sedation that is routinely used in participating ICUs. After inclusion, the mechanical ventilation protocol must be initiated within two hours (if not already being used). In both groups, deep sedation followed by neuromuscular blockade must be initiated within four hours of inclusion.
Blood sample will be collected at different times after the onset of sevoflurane administration and after its cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Inhaled sedation with sevoflurane, will be vaporized via the miniaturized Anesthesia Conserving Device (AnaConDa-S®, Sedana Medical, Uppsala, Sweden). Sevoflurane infusion rate will be adapted from manufacturer's instructions in order to reach a target of expired sevoflurane fraction (FEsevo) of 0.8-1.1. Mechanical ventilation will be protocolized in both arms, based on recent results of a RCT from our group, in which 90-day survival was improved in patients with nonfocal ARDS when an individualized ventilation strategy was applied, compared to the ARDSNet strategy (PEEP set according to FiO2). We will recommend sites wait at least 12 hours before proning, as in the PROSEVA study. In both groups, patients will receive cisatracurium besylate for neuromuscular blockade, and deep sedation will be protocolized to Richmond Agitation-Sedation Scale (RASS) of -4 to -5 (Ramsay of 5-6, or Riker of 1-2) before starting, and during, the cisatracurium besylate infusion.
| Arm | Type | Receives |
|---|---|---|
| Nonfocal ARDS | Experimental | Drug: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNtsARDS patient with nonfocal lung imaging phenotype |
| Focal ARDS | Experimental | Drug: Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNtsARDS patient with focal lung imaging phenotype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Presence for ≤ 12 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms :
- a PaO2/FiO2 < 200 mmHg with positive end-expiratory pressure (PEEP) ≥ 8 cmH2O (or, if arterial blood gas not available : SpO2/FiO2 ratio that is equivalent to a PaO2/FiO2 < 200 mmHg with PEEP ≥8 cmH2O, and a confirmatory SpO2/FiO2 ratio between 1-6 hours after the initial SpO2/FiO2 ratio determination) b Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules c Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present
Key exclusion criteria (19 listed)
- Lack of informed consent
- Continuous sedation with inhaled sevoflurane at enrollment
- Currently receiving ECMO therapy
- Chronic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
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 |
|---|---|---|
| Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNtsPharmacokinetic of inhaled sevoflurane used for sedation | Drug | Focal ARDS, Nonfocal ARDS |
Primary outcome
Plasma concentrations of sevoflurane
Time frame: 5 minutes after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 30 minutes after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 1 hour after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 6 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 24 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 48 hours after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 5 minutes after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 30 minutes after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 1 hour after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 4 hours after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
Plasma concentrations of sevoflurane
Time frame: 6 hours after the cessation of sevoflurane administration
Plasma concentrations of sevoflurane
7 secondary outcomes
Plasma concentration of hexafluoroisopropanolol
Time frame: Until sedation can be definitely interrupted or until day 7
Fraction of inspired sevoflurane
Time frame: Until sedation can be definitely interrupted or until day 7
Fraction of expired sevoflurane
Time frame: Until sedation can be definitely interrupted or until day 7
Dose of sevoflurane
Time frame: Until sedation can be definitely interrupted or until day 7
Infusion duration of sevoflurane
Time frame: Until sedation can be definitely interrupted or until day 7
Infusion rate of remifentanil
Time frame: Until sedation can be definitely interrupted or until day 7
Values of a bispectral index
Time frame: Until sedation can be definitely interrupted or until day 7
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Raiko Blondonnet, MD, MSc principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 Dec 2023. 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.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Plasma concentrations of sevoflurane (time frame: 5 minutes after the detection by the monitor of sevoflurane (0.1%) in the breathing circuit). The study lists 11 primary outcomes in all. 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 19 Dec 2023.