Back to results

Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation (SEVOCOPD)

Primary Purpose

COPD Exacerbation, Invasive Mechanical Ventilation

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sevoflurane

Propofol

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD exacerbation, Sevoflurane, Airway Resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sevoflurane group

Propofol group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum pressure

PEEPi

PEEPtot

Trapped volume

Gas exchange by the help of blood gases

Heterogeneity of alveolar ventilation by electro-impedancemetry

Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages

Thickness of the diaphragm measured by ultrasound

Full Information

NCT ID

NCT03460015

First Posted

February 1, 2018

Last Updated

December 23, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03460015

Brief Title

Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

Acronym

SEVOCOPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

September 19, 2020 (Actual)

Study Completion Date

December 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD Exacerbation, Invasive Mechanical Ventilation

Keywords

COPD exacerbation, Sevoflurane, Airway Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane group

Arm Type

Experimental

Arm Title

Propofol group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evolution of airway resistance before and after sevoflurane in COPD patients

Description

Time Frame

Hour 48

Secondary Outcome Measure Information:

Title

Maximum pressure

Time Frame