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Observational Study on the Clinical Impact of Desaturation During Liver Surgery

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ClinicalTrials.gov Identifier: NCT01458262
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : January 29, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

September 22, 2011
October 24, 2011
January 29, 2014
September 2011
October 2013   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01458262 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study on the Clinical Impact of Desaturation During Liver Surgery
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patient undergoing hepatic surgery or liver transplantation
Cerebral Desaturation
Other: systemic and cerebral oxymetry
oxymetry measurement using near infrared spectroscopy
Other Name: oxymetry measurement using near infrared spectroscopy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2014
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01458262
CE10.192
No
Not Provided
Not Provided
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Medtronic - MITG
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
Centre hospitalier de l'Université de Montréal (CHUM)
January 2014