Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

NCT ID: NCT04040478

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-15

Study Completion Date

2020-04-01

Brief Summary

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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

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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

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Transcutaneous Monitoring Microcirculation Peripheral Perfusion Tissue Metabolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal

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.

Transcutaneous monitoring

Intervention Type 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.

Vascular

20 patients undergoing femoral endarterectomy.

Transcutaneous monitoring

Intervention Type 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.

Interventions

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Transcutaneous 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients not able to give a informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiometer Medical ApS

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Eske Kvanner Aasvang

Head of research, Principal investigator, ass. professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eske Aasvang, MD phD DMSci

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35767233 (View on PubMed)

Other Identifiers

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TCM study

Identifier Type: -

Identifier Source: org_study_id

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