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

Phase 3RecruitingNCT04341350

University Hospital, Brest250 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

CH Bourges

Bourges, France

RECRUITING

CHU de Brest

Brest, France

RECRUITING

CH Corbeil Essonnes

Corbeil-Essonnes, France

RECRUITING

CH Le Mans

Le Mans, France

RECRUITING

GHBS Lorient

Lorient, France

RECRUITING

CH Melun

Melun, France

RECRUITING

CHU Montpellier

Montpellier, France

SUSPENDED

CH Morlaix

Morlaix, France

RECRUITING

CHU Poitiers

Poitiers, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

Occurrence of a delirium in intensive care

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

Time frame: 28 days

Secondary Outcomes

Mortality in intensive care

Mortality in intensive care will be observed

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

Mortality at day 28

Mortality at day 28 will be observed

Time frame: 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.

Time frame: 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

Time frame: 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

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

Cumulative dose anesthetics drugs

Cumulative dose anesthetics drugs will be observed

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

Duration of anesthetics drugs

Duration of anesthetics drugs will be observed

Time frame: 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

Time frame: 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

Time frame: 28 days

Incidence of delirium

Incidence of delirium will be observed

Time frame: 28 days

Duration of delirium

Duration of delirium will be observed

Time frame: 28 days

Length of ICU stay

Length of ICU stay will be calculated

Time frame: 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

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

Self aggressive act

Self aggressive act will be observed

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

Hetero-aggressive act

Hetero-aggressive act will be observed

Time frame: 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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts