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Observational Study on the Clinical Impact of Desaturation During Liver Surgery

NCT ID: NCT01458262

Last Updated: 2014-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Desaturation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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systemic and cerebral oxymetry

oxymetry measurement using near infrared spectroscopy

Intervention Type OTHER

Other Intervention Names

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oxymetry measurement using near infrared spectroscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de Recherche du Centre Hospitalier de l'Université de Montréal

OTHER

Sponsor Role collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck Vandenbroucke-Menu, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Réal Lapointe, MD-FRCS

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

André Denault, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Locations

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Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CE10.192

Identifier Type: -

Identifier Source: org_study_id

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