Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation (SEVOCOPD)

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

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,

Study Overview

• Status: Terminated
• Conditions: COPD Exacerbation; Invasive Mechanical Ventilation
• Intervention / Treatment: Drug: Sevoflurane; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34295
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sevoflurane group	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.
Active Comparator: Propofol group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Boris Jung, MD PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 19, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Sevoflurane; Airway Resistance; COPD exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Disease Progression; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: 9856

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No