Traumatic Brain InjuryIsoSAFENCT06311604
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients
A study testing Isoflurane in people with Traumatic Brain Injury, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2024to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient > 18 years old
- Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
- On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours, with a RASS of between -3 and -5
- Initial ICP < 15 mmHg on introduction of isoflurane
- Functional intracranial pressure sensor
- Transcranial Doppler measurements performed within 24 hours
- Written informed consent from a legal representative/relative/trusted person. In the absence of a legal representative, the patient may be included under the emergency procedure.
Who cannot join
- Patients who have had a decompressive craniectomy
- Patients with a personal or family history of malignant hyperthermia
- Patients with a history of long QT syndrome
- Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
- Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
- Patients who have experienced liver damage, jaundice, unexplained fever, or eosinophilia after administration of a halogenated anaesthetic.
Show all 11Show fewer
- Patients expected to die within the next 24 hours
- Subject in a period of exclusion from another clinical trial,
- Technical unavailability of the inhaler
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
- No European social security
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, Choisir Une Région, 38043
barthélémy H Grenoble, MD, +33476766879, bbertrand4@chu-grenoble.fr
Anais ADOLLE, +33476766879, aadolle@chu-grenoble.fr
About this study
Official title: Evaluation of the Safety of Inhaled Sedation With Isoflurane in Patients With Severe Traumatic Brain Injury
Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.
Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.
Read more
The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.
The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP.
Read the detailed description
Intensive care management of patients with severe neurological injury regularly involves deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with morphine, with the aim of preventing and/or treating episodes of intracranial hypertension (ICHT). However, the tachyphylaxis associated with intravenous hypnotics requires a continuous increase in the doses administered to maintain the same level of sedation, or even a combination of several pharmacological classes. This progressive tolerance to hypnotics may result in the failure of the sedation strategy for certain neuro-injured patients and/or expose them to the undesirable effects of high doses of intravenous hypnotics: haemodynamic instability, longer periods of mechanical ventilation, neuromyopathy, mental confusion and withdrawal syndrome.
Inhaled halogens are a class of hypnotics used daily in the operating theatre to maintain anaesthesia. At the doses used in anaesthesia (> 1 MAC - Minimal Alveolar Concentration), they are contraindicated in neuro-injured patients at risk of HTIC because of their cerebral vasodilatory effects, which can lead to an increase in intracranial pressure (ICP) and compromise cerebral perfusion. Halogens (Isoflurane, Sevoflurane) can be used in intensive care with appropriate medical devices (Isoconda, Mirus). They are used at more moderate doses (< 1 MAC) because they are combined with intravenous hypnotics and because there is no surgical stimulus. Several clinical studies in general intensive care have shown improved sedation quality, reduced duration of mechanical ventilation, quicker awakening and shorter time to tracheal extubation, and lower costs in the group treated with a halogenated agent compared with the control group receiving midazolam or propofol. At these low concentrations, the effects on ICP and intracerebral haemodynamics are much less marked, according to the studies published on this subject. In addition, beneficial effects on the volume of cerebral ischaemia have been shown in animal models treated with halogenated agents. However, there is a need for a precise study of the benefit-risk ratio of using halogenated agents in neurological patients.
The Anaesthesia and Intensive Care Unit at the CHUGA has been internationally recognised for many years in the management of sedation-analgesia in intensive care. In connection with this, the experience acquired by the CHUGA's neuro-resuscitation unit in brain monitoring will be used to explore in detail the effects of halogenated agents on intracerebral haemodynamics and intracranial pressure.
the investigator hypothesise that the administration of Isoflurane at 0.7 MAC can be used in this population without deleterious effect on ICP.
- Conditions
- Traumatic Brain Injury
- Being tested
- Isoflurane
- Keywords
- isoflurane, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Inclusions will have 4 phases according to gradual increased doses of isoflurane:
Phase 1: Inclusion of 3 patients with 0.3 MAC isoflurane. In the absence of an increase of ICP > 20% from baseline, inhaled sedation is maintained for 24 hours until the primary endpoint is assessed. If there one patient who does not tolerate this threshold, three additional patients will be included in this phase. A maximum of one treatment failure (see definition below) is tolerated in the phase 1
Phase 2: Inclusion of 3 additional patients with isoflurane dosage of 0.5 MAC under the same conditions as phase 1.
Phase 3: Inclusion of 3 additional patients with isoflurane dosage of 0.7 MAC under the same conditions as phases 1 and 2.
Phase 4: Inclusion of 12-15 additional patients will be included at the 0.7 MAC dose, to have 18 patients exposed to 0.7 MAC isoflurane.
| Study group | Role | What they receive |
|---|---|---|
| ISOFLURANE SEDATION | Experimental | Inclusions will have 4 phases according to gradual increased doses of isoflurane (0.3 MAC; 0.5 MAC and 0.7 MAC) Upgrading dose of isoflurane in each phase will be validated by an independent data and safety monitoring committee (DSMC).
Inclusion of 12-15 additional patients will be included at the 0.7 MAC dose, to have 18 patients exposed to 0.7 MAC isoflurane. Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure.
Composite criterion :
- Deaths (attributable to isoflurane) at "H+24 target MAC reached".
- 2 consecutive hourly averages of ICP > 20 mmHg during the 24 hours after the target MAC has been reached will be considered as a failure.
Measured: 36 hours
Secondary outcomes (10)
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Changes between "before introduction" and "H+24 MAC target reached of transcranial Doppler parameters
Measured: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Changes between "before introduction" and "H+24 MAC target reached of Tissue oxygen pressure if applicable
Measured: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Changes between "before introduction" and "H+24 MAC target reached" in Cerebral Perfusion Pressure = MAP - ICP
Measured: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Changes between "before introduction" and "H+24 MAC target reached" in ICP dose
Measured: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Changes between "before introduction", "H+24 target MAC reached" in biology parameters
Measured: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Changes between "before introduction", "H+24 target MAC reached" in Dose of noradrenaline; volume of filling fluids administered
Measured: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Changes between "before introduction", "H+24 target MAC reached" in DVE: drainage level, drainage volume/24h
Measured: 36 hours
To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients
Change between "before introduction" and "H+24 MAC target reached" in the dose of intravenous hypnotics consumed
Measured: 36 hours
To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma
Rate of non-insertion of isoflurane administration device: cause of withdrawal before "H+24 after target MAC reached".
Measured: 36 hours
To assess the neurological outcome at D28 after inhaled sedation in head trauma patients
Neurological outcome at D28 assessed using the Glasgow Outcome Scale (GOSe). 1-4 = poor outcome 4-8 = good outcome
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Jun 2024
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, single-centre, interventional dose escalation study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- barthélémy BERTRAND, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311604
- Sponsor's protocol ID
- 38RC22.0272
- Acronym
- IsoSAFE
- Status last verified
- Jun 2024
- First submitted
- 21 Aug 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.
PubMed 34454654Bosel J, Purrucker JC, Nowak F, Renzland J, Schiller P, Perez EB, Poli S, Brunn B, Hacke W, Steiner T. Volatile isoflurane sedation in cerebrovascular intensive care patients using AnaConDa((R)): effects on cerebral oxygenation, circulation, and pressure. Intensive Care Med. 2012 Dec;38(12):1955-64. doi: 10.1007/s00134-012-2708-8. Epub 2012 Oct 25.
PubMed 23096426Villa F, Iacca C, Molinari AF, Giussani C, Aletti G, Pesenti A, Citerio G. Inhalation versus endovenous sedation in subarachnoid hemorrhage patients: effects on regional cerebral blood flow. Crit Care Med. 2012 Oct;40(10):2797-804. doi: 10.1097/CCM.0b013e31825b8bc6.
PubMed 22824929Codaccioni JL, Velly LJ, Moubarik C, Bruder NJ, Pisano PS, Guillet BA. Sevoflurane preconditioning against focal cerebral ischemia: inhibition of apoptosis in the face of transient improvement of neurological outcome. Anesthesiology. 2009 Jun;110(6):1271-8. doi: 10.1097/ALN.0b013e3181a1fe68.
PubMed 19417596Aubanel S, Bruiset F, Chapuis C, Chanques G, Payen JF. Therapeutic options for agitation in the intensive care unit. Anaesth Crit Care Pain Med. 2020 Oct;39(5):639-646. doi: 10.1016/j.accpm.2020.01.009. Epub 2020 Aug 7.
PubMed 32777434
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Inhaled Sedation With Isoflurane in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06311604
- Acronym / sponsor ID
- IsoSAFE / 38RC22.0272
- Conditions
- Traumatic Brain Injury
- Keywords
- isoflurane, traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 15 Mar 2024 (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.
Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome.
Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure.
The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population.
The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP.
Detailed description
Intensive care management of patients with severe neurological injury regularly involves deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with morphine, with the aim of preventing and/or treating episodes of intracranial hypertension (ICHT). However, the tachyphylaxis associated with intravenous hypnotics requires a continuous increase in the doses administered to maintain the same level of sedation, or even a combination of several pharmacological classes. This progressive tolerance to hypnotics may result in the failure of the sedation strategy for certain neuro-injured patients and/or expose them to the undesirable effects of high doses of intravenous hypnotics: haemodynamic instability, longer periods of mechanical ventilation, neuromyopathy, mental confusion and withdrawal syndrome.
Inhaled halogens are a class of hypnotics used daily in the operating theatre to maintain anaesthesia. At the doses used in anaesthesia (> 1 MAC - Minimal Alveolar Concentration), they are contraindicated in neuro-injured patients at risk of HTIC because of their cerebral vasodilatory effects, which can lead to an increase in intracranial pressure (ICP) and compromise cerebral perfusion. Halogens (Isoflurane, Sevoflurane) can be used in intensive care with appropriate medical devices (Isoconda, Mirus). They are used at more moderate doses (< 1 MAC) because they are combined with intravenous hypnotics and because there is no surgical stimulus. Several clinical studies in general intensive care have shown improved sedation quality, reduced duration of mechanical ventilation, quicker awakening and shorter time to tracheal extubation, and lower costs in the group treated with a halogenated agent compared with the control group receiving midazolam or propofol. At these low concentrations, the effects on ICP and intracerebral haemodynamics are much less marked, according to the studies published on this subject. In addition, beneficial effects on the volume of cerebral ischaemia have been shown in animal models treated with halogenated agents. However, there is a need for a precise study of the benefit-risk ratio of using halogenated agents in neurological patients.
The Anaesthesia and Intensive Care Unit at the CHUGA has been internationally recognised for many years in the management of sedation-analgesia in intensive care. In connection with this, the experience acquired by the CHUGA's neuro-resuscitation unit in brain monitoring will be used to explore in detail the effects of halogenated agents on intracerebral haemodynamics and intracranial pressure.
the investigator hypothesise that the administration of Isoflurane at 0.7 MAC can be used in this population without deleterious effect on ICP.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, single-centre, interventional dose escalation study
| Arm | Type | Receives |
|---|---|---|
| ISOFLURANE SEDATION | Experimental | Drug: IsofluraneInclusions will have 4 phases according to gradual increased doses of isoflurane (0.3 MAC; 0.5 MAC and 0.7 MAC) Upgrading dose of isoflurane in each phase will be validated by an independent data and safety monitoring committee (DSMC). Inclusion of 12-15 additional patients will be included at the 0.7 MAC dose, to have 18 patients exposed to 0.7 MAC isoflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient > 18 years old
- Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
- On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours, with a RASS of between -3 and -5
- Initial ICP < 15 mmHg on introduction of isoflurane
- Functional intracranial pressure sensor
Key exclusion criteria (11 listed)
- Patients who have had a decompressive craniectomy
- Patients with a personal or family history of malignant hyperthermia
- Patients with a history of long QT syndrome
- Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
- Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
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 |
|---|---|---|
| IsofluraneInclusions will have 4 phases according to gradual increased doses of isoflurane: Phase 1: Inclusion of 3 patients with 0.3 MAC isoflurane. In the absence of an increase of ICP > 20% from baseline, inhaled sedation is maintained for 24 hours until the primary endpoint is assessed. If there one patient who does not tolerate this threshold, three additional patients will be included in this phase. A maximum of one treatment failure (see definition below) is tolerated in the phase 1 Phase 2: Inclusion of 3 additional patients with isoflurane dosage of 0.5 MAC under the same conditions as phase 1. Phase 3: Inclusion of 3 additional patients with isoflurane dosage of 0.7 MAC under the same conditions as phases 1 and 2. Phase 4: Inclusion of 12-15 additional patients will be included at the 0.7 MAC dose, to have 18 patients exposed to 0.7 MAC isoflurane. | Drug | ISOFLURANE SEDATION |
Primary outcome
To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure.
Time frame: 36 hours
Composite criterion : 1. Deaths (attributable to isoflurane) at "H+24 target MAC reached". 2. 2 consecutive hourly averages of ICP > 20 mmHg during the 24 hours after the target MAC has been reached will be considered as a failure.
10 secondary outcomes
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Time frame: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Time frame: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Time frame: 36 hours
To assess the effect on cerebral blood flow of inhaled isoflurane sedation in patients with cranial trauma.
Time frame: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Time frame: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Time frame: 36 hours
To assess the extra-neurological effects of inhaled isoflurane sedation in head trauma patients
Time frame: 36 hours
To assess the savings in intravenous hypnotics associated with isoflurane inhalation sedation in head trauma patients
Time frame: 36 hours
To assess the feasibility of inhaled sedation with isoflurane in patients with head trauma
Time frame: 36 hours
To assess the neurological outcome at D28 after inhaled sedation in head trauma patients
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 34454654Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.
- Background: PubMed 23096426Bosel J, Purrucker JC, Nowak F, Renzland J, Schiller P, Perez EB, Poli S, Brunn B, Hacke W, Steiner T. Volatile isoflurane sedation in cerebrovascular intensive care patients using AnaConDa((R)): effects on cerebral oxygenation, circulation, and pressure. Intensive Care Med. 2012 Dec;38(12):1955-64. doi: 10.1007/s00134-012-2708-8. Epub 2012 Oct 25.
- Background: PubMed 22824929Villa F, Iacca C, Molinari AF, Giussani C, Aletti G, Pesenti A, Citerio G. Inhalation versus endovenous sedation in subarachnoid hemorrhage patients: effects on regional cerebral blood flow. Crit Care Med. 2012 Oct;40(10):2797-804. doi: 10.1097/CCM.0b013e31825b8bc6.
- Background: PubMed 19417596Codaccioni JL, Velly LJ, Moubarik C, Bruder NJ, Pisano PS, Guillet BA. Sevoflurane preconditioning against focal cerebral ischemia: inhibition of apoptosis in the face of transient improvement of neurological outcome. Anesthesiology. 2009 Jun;110(6):1271-8. doi: 10.1097/ALN.0b013e3181a1fe68.
- Background: PubMed 32777434Aubanel S, Bruiset F, Chapuis C, Chanques G, Payen JF. Therapeutic options for agitation in the intensive care unit. Anaesth Crit Care Pain Med. 2020 Oct;39(5):639-646. doi: 10.1016/j.accpm.2020.01.009. Epub 2020 Aug 7.
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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.
barthélémy BERTRAND, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane in people with Traumatic Brain Injury, run by University Hospital, Grenoble 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 7 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: looking for participants now, as of the sponsor's last update on 3 Jul 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact barthélémy BERTRAND, MD (+33 476766879, bbertrand4@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of sedation with 0.7 MAC of inhaled isoflurane in cranial trauma patients in terms of intracranial pressure. (time frame: 36 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 NCT06311604, which also lists 5 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 3 Jul 2024.