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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention The study was terminated prematurely due to inclusion difficulties
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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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane group | Experimental |
| |
| Propofol group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pressure | Evolution between Hour 0 and Hour 48 | |
| PEEPi | Evolution between Hour 0 and Hour 48 | |
| PEEPtot |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Boris Jung, MD PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Montpellier | Hérault | 34295 | France |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Propofol | Drug | 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. |
|
| 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 |
| 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 |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |