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Completed

NCT Number: NCT01458262

Observational Study on the Clinical Impact of Desaturation During Liver Surgery

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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Key information

Conditions

Cerebral Desaturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

systemic and cerebral oxymetry

Other

oxymetry measurement using near infrared spectroscopy

Other names: oxymetry measurement using near infrared spectroscopy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Medtronic - MITG

Registry information

Official study title

Observational Study on the Clinical Impact of Systemic and Cerebral Desaturation During Liver Transplantation and Hepatectomy

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 24, 2011
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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