Intraoperative Optimisation of Tissue Oxygenation

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

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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Monitoring and optimizing tissue oxygenation (StO2) in high-risk surgery and/or high-risk surgical patients may decrease the risk of postoperative complications.

Tissue hypoxia occurs frequently during high-risk surgery in high-risk patients. The investigators want to see if an algorithm aimed at optimizing intraoperative tissue oxygenation reduces perioperative complications as well as length of stay in the intensive care unit (ICU LOS), 28-day mortality, and the duration of mechanical ventilation in these patients.

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Detailed Description

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Conditions

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Higk Risk Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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standard care

The data from the InSPectra Monitor in the Control group will be inaccessible for the Investigator since this is not a part of their daily medical practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment group,

The data given by the monitor will be available for the Investigator and used to apply the optimization protocol

Group Type ACTIVE_COMPARATOR

connected to the InSpectra Monitor

Intervention Type DEVICE

Interventions

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connected to the InSpectra Monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

. Major elective surgery

* Aged over 65 years with moderate functional limitation of one or more organ systems
* ASA classification III or IV, i.e. severe cardiac, vascular, respiratory or metabolic illness resulting in severe functional limitation
* Routine use of arterial and central venous lines
* Planned postoperative stay on ICU or PACU

Exclusion Criteria

* Refusal of consent
* acute myocardial ischemia prior to enrolment
* patients receiving palliative treatment only
* disseminated malignancy
* patients unlikely to survive more than 6 hours
* emergency surgery
* transplantations
* neurosurgical patients
* patients undergoing extensive liver surgery requiring low CVP management

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No