Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

NCT03460015 | Terminated DMC

• 1 other identifier: 9856
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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,

Conditions

COPD Exacerbation; Invasive Mechanical Ventilation

Keywords

COPD exacerbation; Sevoflurane; Airway Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Sevoflurane group

EXPERIMENTAL

Drug: Sevoflurane; Drug: Propofol

Propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Sevoflurane 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).

Sevoflurane group

Propofol 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; Sevoflurane group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Boris Jung, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: March 9, 2018
• Study Start: March 1, 2018
• Primary Completion: September 19, 2020
• Study Completion: December 16, 2020
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

FR (1)