Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

COPD Exacerbation Clinical Trial

— SEVOCOPD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03460015
• Other study ID #: 9856
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• COPD Exacerbation
• Disease Progression
• Invasive Mechanical Ventilation
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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