Observational Study on the Clinical Impact of Desaturation During Liver Surgery

This study has been completed.
Sponsor:
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: January 27, 2014
Last verified: January 2014
  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 ]

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

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

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
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: January 27, 2014
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 April 17, 2014