NCT03460015

Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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,

Conditions

• COPD Exacerbation
• Invasive Mechanical Ventilation

Interventions

Type	Name	Description
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).
DRUG	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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-09-19
• Completion: 2020-12-16
• First posted: 2018-03-09
• Last updated: 2021-12-28

Locations

1 site across 1 country: France