COPD ExacerbationSEVOCOPDNCT03460015
Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation
A study testing Sevoflurane and Propofol in people with COPD Exacerbation and Invasive Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Invasive Mechanical Ventilation
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 16 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study
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
- Being tested
- Sevoflurane, Propofol
- Keywords
- COPD exacerbation, Sevoflurane, Airway Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
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).
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Experimental | Not described Receives: Drug: Sevoflurane; Drug: Propofol |
| Propofol group | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hour 48
Secondary outcomes (8)
Maximum pressure
Measured: Evolution between Hour 0 and Hour 48
PEEPi
Measured: Evolution between Hour 0 and Hour 48
PEEPtot
Measured: Evolution between Hour 0 and Hour 48
Trapped volume
Measured: Evolution between Hour 0 and Hour 48
Gas exchange by the help of blood gases
Measured: Evolution between Hour 0 and Hour 48
Heterogeneity of alveolar ventilation by electro-impedancemetry
Measured: Evolution between Hour 0 and Hour 48
Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages
Measured: Evolution between Hour 0 and Hour 48
Thickness of the diaphragm measured by ultrasound
Measured: Evolution between Hour 0 and Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Mar 2018
- Primary completion19 Sep 2020
- Study completion16 Dec 2020
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Jung, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460015
- Sponsor's protocol ID
- 9856
- Acronym
- SEVOCOPD
- Status last verified
- Dec 2021
- First submitted
- 1 Feb 2018
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation in Intensive Care Unit: A Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT03460015
- Acronym / sponsor ID
- SEVOCOPD / 9856
- Conditions
- COPD Exacerbation, Invasive Mechanical Ventilation
- Keywords
- COPD exacerbation, Sevoflurane, Airway Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Experimental | Drug: Sevoflurane, Drug: Propofol |
| Propofol group | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneDuring 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 | Sevoflurane group |
| PropofolIn 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. | Drug | Propofol group, Sevoflurane group |
Primary outcome
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.
8 secondary outcomes
Maximum pressure
Time frame: Evolution between Hour 0 and Hour 48
PEEPi
Time frame: Evolution between Hour 0 and Hour 48
PEEPtot
Time frame: Evolution between Hour 0 and Hour 48
Trapped volume
Time frame: Evolution between Hour 0 and Hour 48
Gas exchange by the help of blood gases
Time frame: Evolution between Hour 0 and Hour 48
Heterogeneity of alveolar ventilation by electro-impedancemetry
Time frame: Evolution between Hour 0 and Hour 48
Proinflammatory cytokines (IL1, IL6, TNFalpha) and sRAGE measurements in miniBroncho-Alveolar lavages
Time frame: Evolution between Hour 0 and Hour 48
Thickness of the diaphragm measured by ultrasound
Time frame: Evolution between Hour 0 and Hour 48
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Jung, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with COPD Exacerbation and Invasive Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of airway resistance before and after sevoflurane in COPD patients (time frame: Hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.