Thoracic SurgeryBIS1NCT02812745
Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia?
An observational study of Thoracic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. 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?
- recording of cardiac output and other parameters
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Oct 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: patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
Who may be able to join
- Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
- Good echogenicity
- Social security coverage
Who cannot join
- Pregnancy
- Subjects with black skin (a known technical limitation of plethysmography)
- Cardiac arrhythmia
- Sepsis
- Poor echogenicity
- Legal guardianship or incarceration
- Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study
Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.
- Conditions
- Thoracic Surgery
- Being tested
- recording of cardiac output, other parameters
- Keywords
- anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recording of cardiac outputDevice
other parametersDevice
BIS (bispectral index ), PI (perfusion index ), etCO2 (end-tidal carbon dioxide ), and brain NIRS (near-infrared spectroscopy)
| Study group | Role | What they receive |
|---|---|---|
| patients | patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
* recording of cardiac output
* other parameters Receives: Device: recording of cardiac output; Device: other parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between variations in the BIS and variations in cardiac output
as measured by transthoracic echocardiography
Measured: Day 0
Secondary outcomes (3)
correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.
measured by transthoracic echocardiography
Measured: Day 0
correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.
measured by transthoracic echocardiography
Measured: Day 0
correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia
measured by transthoracic echocardiography
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 startOct 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
- NCT02812745
- Sponsor's protocol ID
- PI2015_843_0011
- Acronym
- BIS1
- 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
- Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study
- ClinicalTrials.gov ID
- NCT02812745
- Acronym / sponsor ID
- BIS1 / PI2015_843_0011
- Conditions
- Thoracic Surgery
- Keywords
- anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Oct 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.
Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Device: recording of cardiac output, Device: other parameterspatients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth * recording of cardiac output * other parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
Key inclusion criteria (3 listed)
- Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth
- Good echogenicity
- Social security coverage
Key exclusion criteria (7 listed)
- Pregnancy
- 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 |
|---|---|---|
| recording of cardiac output | Device | patients |
| other parametersBIS (bispectral index ), PI (perfusion index ), etCO2 (end-tidal carbon dioxide ), and brain NIRS (near-infrared spectroscopy) | Device | patients |
Primary outcome
correlation between variations in the BIS and variations in cardiac output
Time frame: Day 0
as measured by transthoracic echocardiography
3 secondary outcomes
correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.
Time frame: Day 0
correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.
Time frame: Day 0
correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia
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 7 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?
correlation between variations in the BIS and variations in cardiac output (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; AzTrials last refreshed its copy on 28 Oct 2026.