Intensive Care VentilationPhase 3NCT01017744
Pressure Support Ventilation With the Anesthetic Conserving Device
A Phase 3 study testing Anesthetic Conserving Device in people with Intensive Care Ventilation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Ventilation
- What is being tested?
- Anesthetic Conserving Device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Aug 2013
- Phase
- Phase 3
- 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
- Adults ICU patients who are no more in acute state, intubated and ventilated in pressure support ventilation with intravenous sedation by remifentanil, with light sedation (RASS -1 to -2).
Who cannot join
- Respiratory distress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation
Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of sevoflurane administered through a new specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care patients. In fact, dead space and resistance generated by the device could cancel and even deteriorate the potential positive effects of sevoflurane on ventilation.
Read the detailed description
Pharmacological sedation is often necessary in mechanical ventilated intubated patient. Since a little time, sevoflurane can be used in the intensive care unit via a specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®, SedanaMedical AB, Uppsala, Sweden) placed between the Y piece of the ventilatory circuit and the endotracheal tube. Sevoflurane is known to have ventilatory interesting effects such as bronchodilatation that can be useful in the treatment of severe asthma. These effects could be of interest in the intensive care ventilated patients. On the other hand, the AnaConDa® device could have negative influence on ventilatory mechanics caused by the increased dead space and the resistance to air flow. This negative effect with worsening of work of breathing (WOB) was demonstrated with classic heat and moister exchanger compared to heated humidifiers in pressure support ventilation (PSV). In this way, we would like to study the mechanical effects of the sevoflurane administered with the AnaConDa® compared to a classic management with a heated humidifier and sedation with intravenous remifentanil in PSV consecutive intensive care patients.
- Conditions
- Intensive Care Ventilation
- Being tested
- Anesthetic Conserving Device
- Keywords
- Anesthetic Conserving Device, Anaconda®, Sevoflurane, Remifentanil, Sedation, Pressure support ventilation, Work of breathing, Intrinsic positive end expiratory pressure, Ventilatory dead space, Intensive care, Weaning of mechanical ventilation, Ventilated ICU patients in PSV, No more in acute state, No respiratory distress, Sedated by intravenous remifentanil, In light sedation as define by a Richmond Agitation Sedation Scale (RASS) of - 1 to - 2.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic Conserving DeviceDevice
- Ventilation in PSV with the Anesthetic Conserving Device with remifentanil
- Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Of Breathing (WOB) measured during the last 5 minutes of the 20 minutes period of each treatment
Measured: during the last 5 minutes of the 20 minutes period of each treatment
Secondary outcomes (1)
Intrinsic positive end expiratory pressure (PEEPi), occlusion pressure (P0,1), peak expiratory resistance, respiratory rate, tidal volume, minute ventilation, death space volume.
Measured: in PSV consecutive intensive care patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care VentilationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, General ICU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017744
- Sponsor's protocol ID
- CHU-0062
- Status last verified
- Sep 2013
- First submitted
- 20 Nov 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
Publications
Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: a prospective study. J Crit Care. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24.
PubMed 19781900
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation
- ClinicalTrials.gov ID
- NCT01017744
- Acronym / sponsor ID
- CHU-0062
- Conditions
- Intensive Care Ventilation
- Keywords
- Anesthetic Conserving Device, Anaconda®, Sevoflurane, Remifentanil, Sedation, Pressure support ventilation, Work of breathing, Intrinsic positive end expiratory pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Nov 2009 (estimated)
- 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.
Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of sevoflurane administered through a new specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care patients. In fact, dead space and resistance generated by the device could cancel and even deteriorate the potential positive effects of sevoflurane on ventilation.
Detailed description
Pharmacological sedation is often necessary in mechanical ventilated intubated patient. Since a little time, sevoflurane can be used in the intensive care unit via a specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®, SedanaMedical AB, Uppsala, Sweden) placed between the Y piece of the ventilatory circuit and the endotracheal tube. Sevoflurane is known to have ventilatory interesting effects such as bronchodilatation that can be useful in the treatment of severe asthma. These effects could be of interest in the intensive care ventilated patients. On the other hand, the AnaConDa® device could have negative influence on ventilatory mechanics caused by the increased dead space and the resistance to air flow. This negative effect with worsening of work of breathing (WOB) was demonstrated with classic heat and moister exchanger compared to heated humidifiers in pressure support ventilation (PSV). In this way, we would like to study the mechanical effects of the sevoflurane administered with the AnaConDa® compared to a classic management with a heated humidifier and sedation with intravenous remifentanil in PSV consecutive intensive care patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ICU patients who are no more in acute state, intubated and ventilated in pressure support ventilation with intravenous sedation by remifentanil, with light sedation (RASS -1 to -2).
Key exclusion criteria (1 listed)
- Respiratory distress.
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 |
|---|---|---|
| Anesthetic Conserving Device* Ventilation in PSV with the Anesthetic Conserving Device with remifentanil * Ventilation in PSV with the Anesthetic Conserving Device with sevoflurane | Device | – |
Primary outcome
Work Of Breathing (WOB) measured during the last 5 minutes of the 20 minutes period of each treatment
Time frame: during the last 5 minutes of the 20 minutes period of each treatment
1 secondary outcome
Intrinsic positive end expiratory pressure (PEEPi), occlusion pressure (P0,1), peak expiratory resistance, respiratory rate, tidal volume, minute ventilation, death space volume.
Time frame: in PSV consecutive intensive care patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Background: PubMed 19781900Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: a prospective study. J Crit Care. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24.
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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.
Jean-Michel CONSTANTIN, General ICU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anesthetic Conserving Device in people with Intensive Care Ventilation, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Work Of Breathing (WOB) measured during the last 5 minutes of the 20 minutes period of each treatment (time frame: during the last 5 minutes of the 20 minutes period of each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017744, which also lists 1 linked publication.
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 4 Sep 2013.