Clinical trial NCT04040478: Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients
Official title: Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients for the Detection of Peripheral Tissue Hypoxia and Hypercapnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcutaneous Monitoring
Microcirculation
Peripheral Perfusion
Tissue Metabolism
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Radiometer Medical ApS
First posted: 2019-07-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Rigshospitalet due to surgery for abdominal cancer (Whipple procedure) and vascular surgery (femoral endarterectomy)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients not able to give a informed consent

Primary outcomes:
measure: Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2
timeFrame: 6 hours
measure: Changes in tcpO2 and tcpCO2 before, during and after the arterial clamping during the surgery.
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske Aasvang, MD phD DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sigvardt E, Rasmussen SM, Eiberg JP, Sorensen HBD, Meyhoff CS, Aasvang EK. Transcutaneous blood gas monitoring and tissue perfusion during common femoral thromboendarterectomy. Scand J Clin Lab Invest. 2022 Jul;82(4):334-340. doi: 10.1080/00365513.2022.2092900. Epub 2022 Jun 29.