Observational Study on the Clinical Impact of Desaturation During Liver Surgery
This study is currently recruiting participants.
Verified August 2011 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Covidien
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01458262
First received: September 22, 2011
Last updated: October 20, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebral Desaturation |
Other: systemic and cerebral oxymetry |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy |
Resource links provided by NLM:
Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: systemic and cerebral oxymetry
oxymetry measurement using near infrared spectroscopy
Other Name: oxymetry measurement using near infrared spectroscopy
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patient undergoing hepatic surgery or liver transplantation
Criteria
Inclusion Criteria:
- patients undergoing an hepatic resection or hepatic transplantation
- patients able to give consent with knowledge of french or english language.
Exclusion Criteria:
- age< 18 years
- patients with cerebral diseases
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458262
Contacts
| Contact: Franck Vandenbroucke-Menu, MD | 514-890-8000 ext 36146 | franck.vandenbroucke@umontreal.ca |
Locations
| Canada, Quebec | |
| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montréal, Quebec, Canada, H2X 3J4 | |
| Sub-Investigator: Andrée Cloutier, MD | |
| Sub-Investigator: Roxanne Allard, MD | |
| Sub-Investigator: Anna Nozza, MD | |
| Sub-Investigator: Luc Massicotte, MD | |
| Sub-Investigator: Alain Deschamps, MD PhD | |
| Sub-Investigator: Fabio Payette, MD | |
| Sub-Investigator: Frédéric Mercier, MD | |
| Sub-Investigator: Myriam Auclair, MD | |
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Covidien
Investigators
| Principal Investigator: | Franck Vandenbroucke-Menu, MD | Centre de Recherche du Centre Hospitalier de l'Université de Montréal |
| Principal Investigator: | Réal Lapointe, MD-FRCS | Centre de Recherche du Centre Hospitalier de l'Université de Montréal |
| Principal Investigator: | André Denault, MD PhD | Centre de Recherche du Centre Hospitalier de l'Université de Montréal |
More Information
No publications provided
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT01458262 History of Changes |
| Other Study ID Numbers: | CE10.192 |
| Study First Received: | September 22, 2011 |
| Last Updated: | October 20, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
cerebral oxymetry systemic oxymetry hepatic surgery liver transplantation |
ClinicalTrials.gov processed this record on May 19, 2013