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Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

NCT ID: NCT03460015

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-12-16

Brief Summary

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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,

Detailed Description

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Conditions

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COPD Exacerbation Invasive Mechanical Ventilation

Keywords

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COPD exacerbation Sevoflurane Airway Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sevoflurane group

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type 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).

Propofol

Intervention Type 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.

Propofol group

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris Jung, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University hospital

Montpellier, Hérault, France

Site Status

Countries

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France

Other Identifiers

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9856

Identifier Type: -

Identifier Source: org_study_id