Clinical trial NCT01458262: Observational Study on the Clinical Impact of Desaturation During Liver Surgery
Official title: Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Desaturation
Keywords: cerebral oxymetry
systemic oxymetry
hepatic surgery
liver transplantation
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Medtronic - MITG
First posted: 2011-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient undergoing hepatic surgery or liver transplantation

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events
timeFrame: from the beginning of anesthesia till 4 hours after the end of the surgery
Secondary outcomes:
measure: define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation
timeFrame: from the beginning of anesthesia till 4 hours after the end of the surgery
measure: define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit
timeFrame: duration of intensive care stay, an expected average of 4 days
measure: validate the equivalence of the systemic and cerebral oxymetry
timeFrame: from the beginning of anesthesia till 4 hours after the end of the surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Franck Vandenbroucke-Menu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Réal Lapointe, MD-FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: André Denault, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: