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Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04040478
Enrollment
30
Registered
2019-07-31
Start date
2019-06-15
Completion date
2020-04-01
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculation, Peripheral Perfusion, Tissue Metabolism, Transcutaneous Monitoring

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.

Interventions

DEVICETranscutaneous 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.

Sponsors

Radiometer Medical ApS
CollaboratorINDUSTRY
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* patients not able to give a informed consent

Design outcomes

Primary

MeasureTime frameDescription
Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO26 hoursPercentage 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.6 hoursChanges in tcpO2 and tcpCO2 before arterial clamping vs after arterial clamping in the leg undergoing surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026