Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

Microcirculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040478
• Other study ID #: TCM study
• Status: Completed
• Start date: June 15, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients undergoing surgery for abdominal cancer

• patients undergoing femoral endarterectomy

Exclusion Criteria:

• patients not able to give a informed consent

Related Conditions & MeSH terms

• Microcirculation
• Peripheral Perfusion
• Tissue Metabolism
• Transcutaneous Monitoring

Intervention

Device:
• Transcutaneous monitoring
Transcutaneous monitoring of oxygen and carbon dioxide by using Radiometer TCM5 flex monitor with 3 electrodes on the patient. Abdominal patients are monitored for 4 hours during surgery and for 2 hours in the Post-Anesthesia Care Unit. Arterial blood gasses are drawn from the arterial line 4 times during surgery and 4 times after surgery. Patients undergoing vascular surgery are monitored for up to 4 hours during surgery.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Radiometer Medical ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2	Percentage changes in tcpO2 and tcpCO2 compared to percentage changes in cardiac output, perfusion index and arterial blood gas analysis of paO2 and paCO2	6 hours
Primary	Changes in tcpO2 and tcpCO2 before, during and after the arterial clamping during the surgery.	Changes in tcpO2 and tcpCO2 before arterial clamping vs after arterial clamping in the leg undergoing surgery	6 hours