Skip to main content
OpenTrials
Completed

NCT Number: NCT04040478

Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients not able to give a informed consent

Treatment and study plan

Transcutaneous monitoring

Device

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.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Radiometer Medical ApS

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.