Cerebral DesaturationNCT01458262
Observational Study on the Clinical Impact of Desaturation During Liver Surgery
An observational study of Cerebral Desaturation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Desaturation
- What is being tested?
- systemic and cerebral oxymetry
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jan 2014
- 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: patient undergoing hepatic surgery or liver transplantation
Who may be able to join
- patients undergoing an hepatic resection or hepatic transplantation
- patients able to give consent with knowledge of french or english language.
Who cannot join
- age< 18 years
- patients with cerebral diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3J4
About this study
Official title: Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy
The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.
Read the detailed description
This is an observational study. Cerebral and systemic oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanet- ics Corporation, Troy, MI) will be performed on all patients with 4 optodes (right and left temporal area, arm and leg). Continuous rSO2 values will be stored on a hard disk with a 15 seconds update within intraoperative period and first 4 hours after the surgery. Desaturation phases (saturation decrease more than 20% of the basal value for more than 15 seconds) will be correlated to operative procedure or events. Postoperative adverse events will be collected. A correlation between desaturation and postoperative adverse events will be done with a multiple linear regression model.
- Conditions
- Cerebral Desaturation
- Being tested
- systemic and cerebral oxymetry
- Keywords
- cerebral oxymetry, systemic oxymetry, hepatic surgery, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic and cerebral oxymetryOther
Also called oxymetry measurement using near infrared spectroscopy
oxymetry measurement using near infrared spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events
Measured: from the beginning of anesthesia till 4 hours after the end of the surgery
Secondary outcomes (3)
define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation
Measured: from the beginning of anesthesia till 4 hours after the end of the surgery
define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit
Measured: duration of intensive care stay, an expected average of 4 days
validate the equivalence of the systemic and cerebral oxymetry
Measured: from the beginning of anesthesia till 4 hours after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral DesaturationStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Franck Vandenbroucke-Menu, MD, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de MontréalRéal Lapointe, MD-FRCS, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de MontréalAndré Denault, MD PhD, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458262
- Sponsor's protocol ID
- CE10.192
- Status last verified
- Jan 2014
- First submitted
- 22 Sep 2011
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy
- ClinicalTrials.gov ID
- NCT01458262
- Acronym / sponsor ID
- CE10.192
- Conditions
- Cerebral Desaturation
- Keywords
- cerebral oxymetry, systemic oxymetry, hepatic surgery, liver transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Medtronic - MITG
- Study start
- Sep 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Oct 2011 (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.
The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.
Detailed description
This is an observational study. Cerebral and systemic oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanet- ics Corporation, Troy, MI) will be performed on all patients with 4 optodes (right and left temporal area, arm and leg). Continuous rSO2 values will be stored on a hard disk with a 15 seconds update within intraoperative period and first 4 hours after the surgery. Desaturation phases (saturation decrease more than 20% of the basal value for more than 15 seconds) will be correlated to operative procedure or events. Postoperative adverse events will be collected. A correlation between desaturation and postoperative adverse events will be done with a multiple linear regression model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient undergoing hepatic surgery or liver transplantation
Key inclusion criteria (2 listed)
- patients undergoing an hepatic resection or hepatic transplantation
- patients able to give consent with knowledge of french or english language.
Key exclusion criteria (2 listed)
- age< 18 years
- patients with cerebral diseases
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 |
|---|---|---|
| systemic and cerebral oxymetryAlso: oxymetry measurement using near infrared spectroscopyoxymetry measurement using near infrared spectroscopy | Other | – |
Primary outcome
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events
Time frame: from the beginning of anesthesia till 4 hours after the end of the surgery
3 secondary outcomes
define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation
Time frame: from the beginning of anesthesia till 4 hours after the end of the surgery
define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit
Time frame: duration of intensive care stay, an expected average of 4 days
validate the equivalence of the systemic and cerebral oxymetry
Time frame: from the beginning of anesthesia till 4 hours after the end of the surgery
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 29 Jan 2014.
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Not yet recruitingPhase 3
Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
Cerebral Desaturation Events, Spine Surgeries
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.
Franck Vandenbroucke-Menu, MD principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Réal Lapointe, MD-FRCS principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
André Denault, MD PhD principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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 Cerebral Desaturation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 2 inclusion and 2 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 29 Jan 2014. 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 Canada. 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?
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events (time frame: from the beginning of anesthesia till 4 hours after the end of the surgery). 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 29 Jan 2014.