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NCT Number: NCT04341350

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH Bourges, Bourges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

Propofol + analgesic drug

Drug

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 drug

Drug

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.

Primary outcomes

  1. Occurrence of a delirium in intensive care

    Time frame: 28 days

    Occurrence of delirium in intensive care will be observed (yes / no)

Secondary outcomes

  1. Mortality in intensive care

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Mortality in intensive care will be observed

  2. Mortality at day 28

    Time frame: 28 days

    Mortality at day 28 will be observed

  3. Hospital cost per patient

    Time frame: Through study completion, an average of 1 year.

    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.

  4. 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 vasopressors or inotropic agents will be observed

  5. Number of days with sedation

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Number of days with sedation will be observed

  6. Cumulative dose anesthetics drugs

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Cumulative dose anesthetics drugs will be observed

  7. Duration of anesthetics drugs

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Duration of anesthetics drugs will be observed

  8. Maximum dose of vasopressors or inotropic agents

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Maximum dose of vasopressors or inotropic agents will be observed

  9. Ventilation free days at 28 days following randomisation

    Time frame: 28 days

    Ventilation free days at 28 days following randomisation will be observed

  10. Incidence of delirium

    Time frame: 28 days

    Incidence of delirium will be observed

  11. Duration of delirium

    Time frame: 28 days

    Duration of delirium will be observed

  12. Length of ICU stay

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Length of ICU stay will be calculated

  13. Requirement of patients physical restraints

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Requirement of physical restraints, of patients with unplanned extubation, unplanned catheter, urinary probe or gastric probe removal will be observed

  14. Self aggressive act

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Self aggressive act will be observed

  15. Hetero-aggressive act

    Time frame: Throuh exit from the intensive care unit, an average of 28 days

    Hetero-aggressive act will be observed

  16. Evaluation of cognitive functions

    Time frame: Through study completion, an average of 1 year.

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study

Acronym: INASED

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2020
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.