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Trial record 29 of 659 for:    Sevoflurane

Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation (SEVOCOPD)

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ClinicalTrials.gov Identifier: NCT03460015
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 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 : February 27, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Evolution of airway resistance before and after sevoflurane in COPD patients [ Time Frame: 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 :
  1. Maximum pressure [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  2. PEEPi [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  3. PEEPtot [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  4. Trapped volume [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  5. Gas exchange by the help of blood gases [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  6. Heterogeneity of alveolar ventilation by electro-impedancemetry [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  7. Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages [ Time Frame: Evolution between Hour 0 and Hour 48 ]
  8. Thickness of the diaphragm measured by ultrasound [ Time Frame: Evolution between Hour 0 and Hour 48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460015


Contacts
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Contact: Boris Jung, MD PhD +33467337736 b-jung@chu-montpellier.fr

Locations
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France
University hospital Recruiting
Montpellier, Hérault, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Boris Jung, MD PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03460015     History of Changes
Other Study ID Numbers: 9856
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
COPD exacerbation
Sevoflurane
Airway Resistance

Additional relevant MeSH terms:
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Sevoflurane
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Progression
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation