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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01458262
Enrollment
100
Registered
2011-10-24
Start date
2011-09-30
Completion date
2014-01-31
Last updated
2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Desaturation

Keywords

cerebral oxymetry, systemic oxymetry, hepatic surgery, liver transplantation

Brief summary

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.

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.

Interventions

OTHERsystemic and cerebral oxymetry

oxymetry measurement using near infrared spectroscopy

Sponsors

Centre de Recherche du Centre Hospitalier de l'Université de Montréal
CollaboratorOTHER
Medtronic - MITG
CollaboratorINDUSTRY
Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse eventsfrom the beginning of anesthesia till 4 hours after the end of the surgery

Secondary

MeasureTime frame
define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantationfrom 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 unitduration of intensive care stay, an expected average of 4 days
validate the equivalence of the systemic and cerebral oxymetryfrom the beginning of anesthesia till 4 hours after the end of the surgery

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026