Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

Completed

• Conditions: Tissue Metabolism; Transcutaneous Monitoring; Microcirculation; Peripheral Perfusion
• Interventions: Device: Transcutaneous monitoring

• Registration Number: NCT04040478
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2019-06-15
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Primary Completion: 2019-12-31
• Study Completion: 2020-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• patients not able to give a informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vascular	Transcutaneous monitoring	20 patients undergoing femoral endarterectomy.
Abdominal	Transcutaneous monitoring	80 patients undergoing surgery for abdominal cancer. Data review for interim analysis will be conducted after the participation of 40 patients to evaluate the requirement for further enrollment.

Primary Outcome Measures

Name	Time	Method
Changes in tcpO2 and tcpCO2 compared to changes in cardiac output, perfusion index and arterial paO2 and paCO2	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.	6 hours	Changes in tcpO2 and tcpCO2 before arterial clamping vs after arterial clamping in the leg undergoing surgery

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark