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Surgical Outcome and Multimodal Monitoring - SOMM

NCT02293473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-04-11

No results posted yet for this study

Summary

This study is designed to test if measuring the depth of anaesthesia, brain tissue oxygenation and haemodynamic parameters and specially designed interventions according to the measurements can improve the outcome of high risk surgical patients undergoing major abdominal surgery.

Conditions

  • Complications

Interventions

DEVICE

LiDCO Rapid

LiDCO Rapid haemodynamic monitor

DEVICE

BIS-Bispectral Index Monitor

Depth of anaesthesia

DEVICE

INVOS-Cerebral Oxygenation Monitor

regional brain tissue oxygenation

OTHER

Standard of care

Using standard of care

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Vesna Novak Jankovic, MD, PhD · UMC Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2017-03-01
Completion
2018-04-10

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293473 on ClinicalTrials.gov