Clinical trial NCT03460015: Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation
Official title: Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD Exacerbation
Invasive Mechanical Ventilation
Keywords: COPD exacerbation
Sevoflurane
Airway Resistance
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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,


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of airway resistance before and after sevoflurane in COPD patients
timeFrame: Hour 48
Secondary outcomes:
measure: Maximum pressure
timeFrame: Evolution between Hour 0 and Hour 48
measure: PEEPi
timeFrame: Evolution between Hour 0 and Hour 48
measure: PEEPtot
timeFrame: Evolution between Hour 0 and Hour 48
measure: Trapped volume
timeFrame: Evolution between Hour 0 and Hour 48
measure: Gas exchange by the help of blood gases
timeFrame: Evolution between Hour 0 and Hour 48
measure: Heterogeneity of alveolar ventilation by electro-impedancemetry
timeFrame: Evolution between Hour 0 and Hour 48
measure: Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages
timeFrame: Evolution between Hour 0 and Hour 48
measure: Thickness of the diaphragm measured by ultrasound
timeFrame: Evolution between Hour 0 and Hour 48
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
state: Hérault
Study officials:
affiliation: University Hospital, Montpellier
name: Boris Jung, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: