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Trial record 22 of 671 for:    CARBON DIOXIDE AND arterial

Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients

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ClinicalTrials.gov Identifier: NCT04040478
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Radiometer Medical ApS
Information provided by (Responsible Party):
Eske Kvanner Aasvang, 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.

Condition or disease Intervention/treatment
Transcutaneous Monitoring Microcirculation Peripheral Perfusion Tissue Metabolism Device: Transcutaneous monitoring

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcutaneous Monitoring of Oxygen and Carbon Dioxide in Surgical Patients for the Detection of Peripheral Tissue Hypoxia and Hypercapnia
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
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.
Device: 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.


Vascular
20 patients undergoing femoral endarterectomy.
Device: 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.





Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to Rigshospitalet due to surgery for abdominal cancer (Whipple procedure) and vascular surgery (femoral endarterectomy)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients not able to give a informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040478


Contacts
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Contact: Eske Aasvang, MD, phD, DMSci +4535453545 eske.kvanner.aasvang.01@regionh.dk
Contact: Emilie Sigvardt, Bsc.Med. +4528254123 emilie.sigvardt@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Radiometer Medical ApS
Investigators
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Principal Investigator: Eske Aasvang, MD phD DMSci Rigshospitalet, Denmark

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Responsible Party: Eske Kvanner Aasvang, Head of research, Principal investigator, ass. professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04040478     History of Changes
Other Study ID Numbers: TCM study
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No