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Clinical Trials/NCT04040478
NCT04040478
Completed
Not Applicable

Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients for the Detection of Peripheral Tissue Hypoxia and Hypercapnia

Rigshospitalet, Denmark1 site in 1 country30 target enrollmentJune 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcutaneous Monitoring
Sponsor
Rigshospitalet, Denmark
Enrollment
30
Locations
1
Primary Endpoint
Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The study will investigate if non-invasive continuous transcutaneous blood gas monitoring can detect tissue perfusion and hypoxemia and the relation to other circulatory parameters such as pulse, blood pressure, cardiac output and arterial saturation.

Detailed Description

Macro circulatory parameters such as cardiac output, mean arterial pressure and arterial oxygen saturation are used to monitor the hemodynamic function and tissue perfusion in surgical patients. Though none of the methods are directly monitoring changes in the metabolism of the tissue. Arterial blood gas analysis is used as the golden standard for the detection of metabolic disturbances before, during and after surgery. Disadvantages of the method are 1) the fact that the technique is invasive to the patient, 2) that the method measures the "total gas" (each tissue's contribution to the blood gas in the total circulating blood) and 3) that the methods only provide a snapshot of the patient's blood gas status. Transcutaneous monitoring can be used as a continuous monitoring of the underlying tissue's carbon dioxide and oxygen levels in patients. The method is already used in neonates as a surrogate for the arterial blood gas analysis. Reduced tissue oxygenation due to inadequate perfusion, will initiate an anaerobic tissue metabolism resulting in low oxygen levels and high carbon dioxide levels. The transcutaneous monitoring can therefore potentially be used to detect tissue hypoxia and become a direct measurement of the underlying tissue metabolism.

Registry
clinicaltrials.gov
Start Date
June 15, 2019
End Date
April 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eske Kvanner Aasvang

Head of research, Principal investigator, ass. professor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • patients undergoing surgery for abdominal cancer
  • patients undergoing femoral endarterectomy

Exclusion Criteria

  • patients not able to give a informed consent

Outcomes

Primary Outcomes

Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2

Time Frame: 6 hours

Percentage changes in tcpO2 and tcpCO2 compared to percentage changes in cardiac output, perfusion index and arterial blood gas analysis of paO2 and paCO2

Changes in tcpO2 and tcpCO2 before, during and after the arterial clamping during the surgery.

Time Frame: 6 hours

Changes in tcpO2 and tcpCO2 before arterial clamping vs after arterial clamping in the leg undergoing surgery

Study Sites (1)

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