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Observational Study on the Clinical Impact of Desaturation During Liver Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458262
First Posted: October 24, 2011
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Medtronic - MITG
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
  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 ]

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 ]
  • 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 ]

Enrollment: 100
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: systemic and cerebral oxymetry
    oxymetry measurement using near infrared spectroscopy
    Other Name: oxymetry measurement using near infrared spectroscopy
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458262


Locations
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Medtronic - MITG
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

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01458262     History of Changes
Other Study ID Numbers: CE10.192
First Submitted: September 22, 2011
First Posted: October 24, 2011
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
cerebral oxymetry
systemic oxymetry
hepatic surgery
liver transplantation