Clinical Trials Directory

Trials / Completed

CompletedNCT04040478

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
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICETranscutaneous monitoringTranscutaneous 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.

Timeline

Start date
2019-06-15
Primary completion
2019-12-31
Completion
2020-04-01
First posted
2019-07-31
Last updated
2021-02-23

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04040478. Inclusion in this directory is not an endorsement.