COPD Exacerbation, Invasive Mechanical Ventilation
Conditions
Keywords
COPD exacerbation, Sevoflurane, Airway Resistance
Brief summary
Prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive mechanical ventilation in ICU. Primary outcome measure: Evolution of airway resistance before and after sevoflurane in COPD patients, Secondary outcomes measures: Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry, Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,
Interventions
DRUGSevoflurane
During the first 30 minutes after randomization, patients will be treated with propofol (same dosage as the propofol group). Once the AnaConDa® system is installed, sevoflurane administration will begin (propofol is stopped).
DRUGPropofol
In the control group, sedation will be maintained with the above objective (RASS between -4 and -5, BIS between 40 and 60) until the patient is extubated. In the sevoflurane group, propofol is administrated during the first 30 minutes after the randomization and when the AnaConDa® system is installed propofol is stopped.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * COPD exacerbation * Invasive mechanical ventilation and sedation for a planned duration of at least 24 hours * Consent * Age ≥ 18 years * Affiliation or beneficiary of a social security scheme
Exclusion criteria
: * Contraindication to the administration of sevoflurane (personal or family history of malignant hyperthermia, allergy or halogenated anesthetic accident, chronic myopathy, halogenated toxic hepatitis, uncontrolled intracranial hypertension, unexplained leukocytosis after anesthesia with a halogenated agent) * Contraindication to the administration of propofol (known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, antecedent of Propofol Related Infusion Syndrome) * Refusal of consent * Guardianship * Age \< 18 years * Pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of airway resistance before and after sevoflurane in COPD patients | Hour 48 | Total airway resistance will be measured using the ventilator by setting a 5s inspiratory pause and to measure the sum of (Pmax-P1)/Flow + (P1-Pplat)/Flow. The mechanical ventilation setting will be standardised during the study period and will be similar between the two groups. |
Secondary
| Measure | Time frame |
|---|---|
| PEEPi | Evolution between Hour 0 and Hour 48 |
| PEEPtot | Evolution between Hour 0 and Hour 48 |
| Trapped volume | Evolution between Hour 0 and Hour 48 |
| Maximum pressure | Evolution between Hour 0 and Hour 48 |
| Heterogeneity of alveolar ventilation by electro-impedancemetry | Evolution between Hour 0 and Hour 48 |
| Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages | Evolution between Hour 0 and Hour 48 |
| Thickness of the diaphragm measured by ultrasound | Evolution between Hour 0 and Hour 48 |
| Gas exchange by the help of blood gases | Evolution between Hour 0 and Hour 48 |
Countries
France
Outcome results
None listed