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Clinical Trials/NCT03460015
NCT03460015
Terminated
Not Applicable

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

University Hospital, Montpellier1 site in 1 country16 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Sevoflurane
Conditions
COPD Exacerbation
Sponsor
University Hospital, Montpellier
Enrollment
16
Locations
1
Primary Endpoint
Evolution of airway resistance before and after sevoflurane in COPD patients
Status
Terminated
Last Updated
4 years ago

Overview

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,

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
December 16, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Sevoflurane group

Intervention: Sevoflurane

Sevoflurane group

Intervention: Propofol

Propofol group

Intervention: Propofol

Outcomes

Primary Outcomes

Evolution of airway resistance before and after sevoflurane in COPD patients

Time Frame: 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 Outcomes

  • Maximum pressure(Evolution between Hour 0 and Hour 48)
  • PEEPi(Evolution between Hour 0 and Hour 48)
  • PEEPtot(Evolution between Hour 0 and Hour 48)
  • Heterogeneity of alveolar ventilation by electro-impedancemetry(Evolution between Hour 0 and Hour 48)
  • Thickness of the diaphragm measured by ultrasound(Evolution between Hour 0 and Hour 48)
  • Trapped volume(Evolution between Hour 0 and Hour 48)
  • Gas exchange by the help of blood gases(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)

Study Sites (1)

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