Observational Study on the Clinical Impact of Desaturation During Liver Surgery

Cerebral Desaturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458262
• Other study ID #: CE10.192
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: January 27, 2014
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Desaturation

Intervention

Other:
• systemic and cerebral oxymetry
oxymetry measurement using near infrared spectroscopy

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Medtronic - MITG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	define the correlation coefficient between the number of systemic and/or cerebral desaturation phases and the number of postoperative adverse events		from the beginning of anesthesia till 4 hours after the end of the surgery	No
Secondary	define the prevalence of systemic and cerebral desaturation phases during hepatic surgery or transplantation		from the beginning of anesthesia till 4 hours after the end of the surgery	No
Secondary	define the correlation coefficient between systemic and/or cerebral desaturation phases and the length of stay in intensive care unit		duration of intensive care stay, an expected average of 4 days	No
Secondary	validate the equivalence of the systemic and cerebral oxymetry		from the beginning of anesthesia till 4 hours after the end of the surgery	No