Thoracic SurgeryBIS2NCT02812758
Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence?
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- transthoracic echocardiography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to May 2017
- Phase
- Observational
- 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
Study population: All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)
Who may be able to join
- All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)
- Good echogenicity
- Social security coverage
Who cannot join
- Pregnancy, legal guardianship
- Subjects with black skin (a known technical limitation of plethysmography)
- Cardiac arrhythmia
- Sepsis
- Poor echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study
Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.
- Conditions
- Thoracic Surgery
- Being tested
- transthoracic echocardiography
- Keywords
- sedation depth, indices of preload dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyDevice
recording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV
| Study group | Role | What they receive |
|---|---|---|
| patients | All sedated, intubated, mechanically ventilated adult patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI) transthoracic echocardiography Receives: Device: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)
Measured: Day 0
Secondary outcomes (1)
The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel LORNE, Md, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812758
- Sponsor's protocol ID
- PI2015_843_0012
- Acronym
- BIS2
- Status last verified
- Apr 2018
- First submitted
- 20 Jun 2016
- Last updated
- 23 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sedation Depth (as Evaluated by the Bispectral Index) Influence Dynamic Indices of Preload Dependence? An Observational, Single-centre Pilot Study
- ClinicalTrials.gov ID
- NCT02812758
- Acronym / sponsor ID
- BIS2 / PI2015_843_0012
- Conditions
- Thoracic Surgery
- Keywords
- sedation depth, indices of preload dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Jun 2016 (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.
Dynamic indices of preload dependence (such as stroke volume variability -SVV , pulse pressure variability - PPV and plethysmograph variability index - PVI ) are reportedly predictive of the response to vascular filling in sedated, mechanically ventilated patients. However, the influence of the sedation depth on these dynamic indices has never been evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Device: transthoracic echocardiographyAll sedated, intubated, mechanically ventilated adult patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI) transthoracic echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)
Key inclusion criteria (3 listed)
- All sedated, intubated, mechanically ventilated adult (over-18) patients admitted for elective cardiac surgery, monitored for sedation depth (with the BIS) and for preload dependence indices (SVV, PPV and PVI)
- Good echogenicity
- Social security coverage
Key exclusion criteria (5 listed)
- Pregnancy, legal guardianship
- Subjects with black skin (a known technical limitation of plethysmography)
- Cardiac arrhythmia
- Sepsis
- Poor echogenicity
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 |
|---|---|---|
| transthoracic echocardiographyrecording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV | Device | patients |
Primary outcome
Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS)
Time frame: Day 0
1 secondary outcome
The proportion of patients that change their preload dependence status during a change in sedation depth (as evaluated by the BIS).
Time frame: Day 0
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 23 Apr 2018.
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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.
Emmanuel LORNE, Md, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 5 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 23 Apr 2018. 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 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?
Values of the dynamic indices (SVV, PPV and PVI) at different sedation levels (as evaluated by the BIS) (time frame: Day 0). 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 23 Apr 2018.