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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03460015
Other study ID # 9856
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 16, 2020

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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,


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date December 16, 2020
Est. primary completion date September 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
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).
Propofol
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.

Locations

Country Name City State
France University hospital Montpellier Hérault

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of airway resistance before and after sevoflurane in COPD patients 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. Hour 48
Secondary Maximum pressure Evolution between Hour 0 and Hour 48
Secondary PEEPi Evolution between Hour 0 and Hour 48
Secondary PEEPtot Evolution between Hour 0 and Hour 48
Secondary Trapped volume Evolution between Hour 0 and Hour 48
Secondary Gas exchange by the help of blood gases Evolution between Hour 0 and Hour 48
Secondary Heterogeneity of alveolar ventilation by electro-impedancemetry Evolution between Hour 0 and Hour 48
Secondary Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages Evolution between Hour 0 and Hour 48
Secondary Thickness of the diaphragm measured by ultrasound Evolution between Hour 0 and Hour 48
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