SEVOCOPD: Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT03460015

Collaborator

(none)

Enrollment

Location

Arms

33.5

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation Invasive Mechanical Ventilation	Drug: Sevoflurane Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Sep 19, 2020

Actual Study Completion Date :

Dec 16, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Evolution of airway resistance before and after sevoflurane in COPD patients [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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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