Prevention of DeliriumPhase 3INASEDNCT04341350
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
A Phase 3 study testing Propofol + analgesic drug and Isoflurane + analgesic drug in people with Prevention of Delirium, run by University Hospital, Brest at 12 sites in France.
Trial summary
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Delirium
- What is being tested?
- Propofol + analgesic drug and Isoflurane + analgesic drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 12 sitesFrance
- Study dates
- 6 Aug 2020to 2 Sep 2026
- Phase
- Phase 3
- 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 aged 18 and over
- Patient requiring mechanical ventilation for at least 24 hours
- The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
- Consent obtained from patient or relative
Who cannot join
- Patient hospitalized for the following reasons for admission:
- Cardiac arrest
- State of refractory epilepticus
- Head trauma
- Stroke
- Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU
Show all 16Show fewer
- Sedation started more than 24 hours ago
- Impairment of cognitive functions and / or dementia
- Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT <30%)
- Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 <100 after ventilatory optimisation))
- PaCO2 at inclusion> 50 mmHg after ventilatory optimisation
- Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion
- Patient under guardianship or curatorship
- Minor patient
- Pregnant or breastfeeding woman
- Patient not affiliated to the social security scheme
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
CH Bourges
Bourges, 18000
CHU de Brest
Brest, 29200
CH Corbeil Essonnes
Corbeil-Essonnes, 91106
CH Le Mans
Le Mans, 72039
GHBS Lorient
Lorient, 56322
CH Melun
Melun, 77000
CHU Montpellier
Montpellier, 34295
CH Morlaix
Morlaix, 29672
CHU Poitiers
Poitiers, 86021
CHU Rennes
Rennes, 35033
CHU Tours - Réanimation Chirurgicale
Tours, 37044
CHU Tours
Tours, 37044
About this study
Official title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Read the detailed description
Sedation-analgesia is used in most patients treated with mechanical ventilation (MV). The usual benzodiazepine and morphine sedation reduces pain and anxiety and allows tolerance of invasive procedures in intensive care. These molecules, used as part of the sedation titration protocol or the daily sedation stop protocol, have improved patient outcomes.
Although necessary, these drugs, by mechanisms still uncertain, would promote the occurrence of resuscitation delirium. Delirium itself responsible for worsening morbidity and mortality (increase in the duration of MV, increase in the length of hospital stay, discussed increase in mortality, long-term cognitive sequelae).
This finding favored the use of new drugs in the sedation strategies of patients on MV. Dexmedetomidine has for example reduced the number of days of delirium, the number of days of coma and even mortality in septic patients. Its large-scale use has however been questioned by a recent study.
Halogenated gases have been used for a long time in anesthesia. Their pharmacodynamics, their positive and adverse effects, their therapeutic margins are well known. Thanks to technical innovations they can be used on resuscitation respirators. Several studies on targeted populations have shown the feasibility and the benefits of this use, in particular, the absence of accumulation, the absence of tachyphylaxis, the broad therapeutic range, the small interindividual variation, the rapidity of efficacy and the speed of awakening. Safety in use for the staff in charge of the patient is established. In addition, their potential neuroprotective effect would make it an anesthetic of choice in the prevention of resuscitation delirium.
- Conditions
- Prevention of Delirium
- Being tested
- Propofol + analgesic drug, Isoflurane + analgesic drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol + analgesic drugDrug
sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl
Isoflurane + analgesic drugDrug
sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Usual sedation | Active comparator | Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. Receives: Drug: Propofol + analgesic drug |
| Inhaled sedation | Experimental | Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug. Receives: Drug: Isoflurane + analgesic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a delirium in intensive care
Occurrence of delirium in intensive care will be observed (yes / no)
Measured: 28 days
Secondary outcomes (16)
Mortality in intensive care
Mortality in intensive care will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Mortality at day 28
Mortality at day 28 will be observed
Measured: 28 days
Hospital cost per patient
The average cost of hospitalization for each patient will be calculated taking into account their length of hospital stay, examinations carried out and medical treatment taken.
Measured: Through study completion, an average of 1 year.
Number of days with vasopressors or inotropic agents
Number of days with vasopressors or inotropic agents will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Number of days with sedation
Number of days with sedation will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Cumulative dose anesthetics drugs
Cumulative dose anesthetics drugs will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Duration of anesthetics drugs
Duration of anesthetics drugs will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Maximum dose of vasopressors or inotropic agents
Maximum dose of vasopressors or inotropic agents will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Ventilation free days at 28 days following randomisation
Ventilation free days at 28 days following randomisation will be observed
Measured: 28 days
Incidence of delirium
Incidence of delirium will be observed
Measured: 28 days
Duration of delirium
Duration of delirium will be observed
Measured: 28 days
Length of ICU stay
Length of ICU stay will be calculated
Measured: Throuh exit from the intensive care unit, an average of 28 days
Requirement of patients physical restraints
Requirement of physical restraints, of patients with unplanned extubation, unplanned catheter, urinary probe or gastric probe removal will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Self aggressive act
Self aggressive act will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Hetero-aggressive act
Hetero-aggressive act will be observed
Measured: Throuh exit from the intensive care unit, an average of 28 days
Evaluation of cognitive functions
Cognitive function will be evaluated at discharge, 3- and 12 months using two kinds of score :
- Cantab test, combining 6 cognitive evaluations with an iPad during a 45-60 minutes medical consultation
- PCLS (Posttraumatic stress disorder Checklist Scale), HADS (Hospital Anxiety and Depression scale), SF36 (medical outcome study short form 36), IADL (instrumental activities of daily living) practised by a clinical research associate
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start6 Aug 2020
- Primary completion14 Sep 2025
- Study completion2 Sep 2026 (estimated)
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 Prevention of DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Bailly, MD, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341350
- Sponsor's protocol ID
- INASED (29BRC19.0280)
- Acronym
- INASED
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Bailly P, Egreteau PY, Ehrmann S, Thille AW, Guitton C, Grillet G, Reizine F, Huet O, Jaber S, Nowak E, L'her E. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial. BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.
PubMed 33608400
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study
- ClinicalTrials.gov ID
- NCT04341350
- Acronym / sponsor ID
- INASED / INASED (29BRC19.0280)
- Conditions
- Prevention of Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 10 Apr 2020 (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 objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Detailed description
Sedation-analgesia is used in most patients treated with mechanical ventilation (MV). The usual benzodiazepine and morphine sedation reduces pain and anxiety and allows tolerance of invasive procedures in intensive care. These molecules, used as part of the sedation titration protocol or the daily sedation stop protocol, have improved patient outcomes.
Although necessary, these drugs, by mechanisms still uncertain, would promote the occurrence of resuscitation delirium. Delirium itself responsible for worsening morbidity and mortality (increase in the duration of MV, increase in the length of hospital stay, discussed increase in mortality, long-term cognitive sequelae).
This finding favored the use of new drugs in the sedation strategies of patients on MV. Dexmedetomidine has for example reduced the number of days of delirium, the number of days of coma and even mortality in septic patients. Its large-scale use has however been questioned by a recent study.
Halogenated gases have been used for a long time in anesthesia. Their pharmacodynamics, their positive and adverse effects, their therapeutic margins are well known. Thanks to technical innovations they can be used on resuscitation respirators. Several studies on targeted populations have shown the feasibility and the benefits of this use, in particular, the absence of accumulation, the absence of tachyphylaxis, the broad therapeutic range, the small interindividual variation, the rapidity of efficacy and the speed of awakening. Safety in use for the staff in charge of the patient is established. In addition, their potential neuroprotective effect would make it an anesthetic of choice in the prevention of resuscitation delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual sedation | Active comparator | Drug: Propofol + analgesic drugSedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. |
| Inhaled sedation | Experimental | Drug: Isoflurane + analgesic drugSedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of an analgesic drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 and over
- Patient requiring mechanical ventilation for at least 24 hours
- The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
- Consent obtained from patient or relative
Key exclusion criteria (16 listed)
- Cardiac arrest
- State of refractory epilepticus
- Head trauma
- Stroke
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 |
|---|---|---|
| Propofol + analgesic drugsedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl | Drug | Usual sedation |
| Isoflurane + analgesic drugsedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl. | Drug | Inhaled sedation |
Primary outcome
Occurrence of a delirium in intensive care
Time frame: 28 days
Occurrence of delirium in intensive care will be observed (yes / no)
16 secondary outcomes
Mortality in intensive care
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Mortality at day 28
Time frame: 28 days
Hospital cost per patient
Time frame: Through study completion, an average of 1 year.
Number of days with vasopressors or inotropic agents
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Number of days with sedation
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Cumulative dose anesthetics drugs
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Duration of anesthetics drugs
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Maximum dose of vasopressors or inotropic agents
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Ventilation free days at 28 days following randomisation
Time frame: 28 days
Incidence of delirium
Time frame: 28 days
Duration of delirium
Time frame: 28 days
Length of ICU stay
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Requirement of patients physical restraints
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Self aggressive act
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Hetero-aggressive act
Time frame: Throuh exit from the intensive care unit, an average of 28 days
Evaluation of cognitive functions
Time frame: Through study completion, an average of 1 year.
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 16 Jun 2026.
- Derived from this study: PubMed 33608400Bailly P, Egreteau PY, Ehrmann S, Thille AW, Guitton C, Grillet G, Reizine F, Huet O, Jaber S, Nowak E, L'her E. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial. BMJ Open. 2021 Feb 19;11(2):e042284. doi: 10.1136/bmjopen-2020-042284.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Pierre Bailly, MD principal investigator
CHRU BREST
12 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 Propofol + analgesic drug and Isoflurane + analgesic drug in people with Prevention of Delirium, run by University Hospital, Brest at 12 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 4 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
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?
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?
Occurrence of a delirium in intensive care (time frame: 28 days). 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 NCT04341350, 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 16 Jun 2026.