Post Anesthesia Care OptimaizationNCT04735380
Agreements Between Transcutaneous and Arterial Monitoring of Oxygen and Carbon Dioxide After Non-cardiac Surgery
An observational study of Post Anesthesia Care Optimaization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary aim of the study is to describe the association between changes in TcO2 and TcCO2 and interventions such as blood transfusion, fluid therapy, respiratory support, use of vasopressors, analgesics, and adverse events during PACU admission. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Anesthesia Care Optimaization
- What is being tested?
- TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be patients undergoing major abdominal, urological, vascular, or orthope-dic surgery.
Who may be able to join
- A scheduled stay at PACU for at least 3 postoperatively.
Who cannot join
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the study is to describe the association between changes in TcO2 and TcCO2 and interventions such as blood transfusion, fluid therapy, respiratory support, use of vasopressors, analgesics, and adverse events during PACU admission. The secondary aim is to describe the agreement between TcPO2 and TcPCO2 and PaO2 and PaCO2 in patients after non-cardiac surgery.
Read the detailed description
Study method The data collection will start 1st of February 2021 and will be finished by 30th of April 2021. Patients will be set up with TCM equipment and an Empatica at the PACU. They will be observed for 2 hours. If an intervention is started before 2 hours and not completed, recordings will continue until 5 minutes after the intervention is completed for a maximum of 1 hour (3 hours maximal observation). The sensor will be placed on the patient's antebrachium. Patients will be set up with TCM equipment as soon as possible after arrival at PACU. Every clinical procedure entailing changes in circulatory and/or respiratory support or medication (appendix 1) will be observed and noted in a timetable (ap-pendix 2). Perfusion index (PI) and a full DASAIM score (Danish Association of Anesthesiology and Intensive Care Medicine) will be noted every 15 minutes. Every ABG analysis of PaO2, PaCO2 and lactate conducted during the observational period will be noted.
Age, sex, BMI (Body Mass Index), ASA-score (American Society of Anesthesiologists physical sta-tus classification), comorbidity (Charlson Comorbidity Index - CCI), baseline laboratory data (hemo-globin and creatinine) and name of surgical procedure will be obtained for each patient. REDCap (Research Electronic Data Capture) will be used as a data management system for the project. The study is a part of the Wireless Assessment of Respiratory and circulatory Distress (WARD) project.
Study materials All patients will be monitored with a TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark). The sensor consists of a Stow-Severinghaus-type TcPCO2 electrode combined with a Clark-type TcPO2 electrode, with values per second for TcPO2, TcPCO2 in kPa and heat effect measured in units of mW. The sensor temperature will automatically be heated to 43.5℃ and calibrated. The sensor membrane will be changed every 28th day. There will be a 20-minute stabilization period from patient setup to valid data capturing. The use of sensors and monitors will be according to the manufacturer's instructions.
As a supplement, patients will be wearing an Empatica, as a measurement for the activity of the autonomic nervous system. The Empatica tracks activity, heartrate, blood volume pulse, skin temper-ature and skin conductance. The Empatica E4 consist of a PPG sensor and an EDA sensor. Data from the E4 will be processed in further studies and is not a part of the statistical analysis in this protocol.
Statistics The primary analysis is changes in TCM readings, and the association between clinical procedures, tested using paired statistics comparing both average (mean) TcPO2 and TcPCO2 during 5 minutes before an intervention versus 5 minutes after an intervention. Depending on the data distribution, either t-test or Wilcoxon test will be used.
Secondary analysis includes:
- Changes in TCM and association with specific intervention including grouping into circulatory and respiratory groups.
- Agreement between TcPO2 and PaO2, TcPCO2 and PaCO2. Agreement between the two tech-niques will be assessed using Bland-Altmann analysis including description of mean differ-ence and limits of agreement(17). In case of left-skewed data, log transformation will be ap-plied. A four-quadrant plot will be constructed to assess trending ability and a concordance rate will be calculated.
Tertiary analysis includes:
- An ANCOVA (analyses of co-variance) of the primary and secondary outcomes, with the following predefined variables: age, sex, BMI, ASA-score, and comorbidity, baseline labora-tory data (hemoglobin and creatinine).
- Agreement between perfusion-index and TCM. Agreement between the two techniques will be assessed using Bland-Altmann analysis including description of mean difference and limits of agreement. In case of left-skewed data, log transformation will be applied. A four-quadrant plot will be constructed to assess trending ability and a concordance rate will be calculated.
All results will be stated with their 95% confidence interval (CI). The significance level will be 5%, meaning p-values under 0.05 will be acknowledged as statistically significant. All analyses will be performed using Python 3.7 and the software program PyCharm.
- Conditions
- Post Anesthesia Care Optimaization
- Being tested
- TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark)Device
Patients undergo 2-3 hrs of observation while wearing the device.
What is being measured
The primary outcome is the main question the study is designed to answer.
TCM changes
The primary outcome is changes in TCM recordings before and after clinical interventions and/or acute severe adverse events.
Measured: 31-08-21
Secondary outcomes (1)
ABG and TCM
The secondary outcome is changes in arterial blood gasses before and after clinical interventions and/or acute severe adverse events if recorded in the PACU.
Measured: 31-08-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2021
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Anesthesia Care OptimaizationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735380
- Sponsor's protocol ID
- P-2020-1159
- Status last verified
- Apr 2025
- First submitted
- 28 Jan 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thy SA, Johansen AO, Thy A, Sorensen HH, Molgaard J, Foss NB, Toft P, Meyhoff CS, Aasvang EK. Associations between clinical interventions and transcutaneous blood gas values in postoperative patients. J Clin Monit Comput. 2023 Oct;37(5):1255-1264. doi: 10.1007/s10877-023-00982-x. Epub 2023 Feb 18.
PubMed 36808596
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreements Between Transcutaneous and Arterial Monitoring of Oxygen and Carbon Dioxide After Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT04735380
- Acronym / sponsor ID
- P-2020-1159
- Conditions
- Post Anesthesia Care Optimaization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to describe the association between changes in TcO2 and TcCO2 and interventions such as blood transfusion, fluid therapy, respiratory support, use of vasopressors, analgesics, and adverse events during PACU admission. The secondary aim is to describe the agreement between TcPO2 and TcPCO2 and PaO2 and PaCO2 in patients after non-cardiac surgery.
Detailed description
Study method The data collection will start 1st of February 2021 and will be finished by 30th of April 2021. Patients will be set up with TCM equipment and an Empatica at the PACU. They will be observed for 2 hours. If an intervention is started before 2 hours and not completed, recordings will continue until 5 minutes after the intervention is completed for a maximum of 1 hour (3 hours maximal observation). The sensor will be placed on the patient's antebrachium. Patients will be set up with TCM equipment as soon as possible after arrival at PACU. Every clinical procedure entailing changes in circulatory and/or respiratory support or medication (appendix 1) will be observed and noted in a timetable (ap-pendix 2). Perfusion index (PI) and a full DASAIM score (Danish Association of Anesthesiology and Intensive Care Medicine) will be noted every 15 minutes. Every ABG analysis of PaO2, PaCO2 and lactate conducted during the observational period will be noted.
Age, sex, BMI (Body Mass Index), ASA-score (American Society of Anesthesiologists physical sta-tus classification), comorbidity (Charlson Comorbidity Index - CCI), baseline laboratory data (hemo-globin and creatinine) and name of surgical procedure will be obtained for each patient. REDCap (Research Electronic Data Capture) will be used as a data management system for the project. The study is a part of the Wireless Assessment of Respiratory and circulatory Distress (WARD) project.
Study materials All patients will be monitored with a TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark). The sensor consists of a Stow-Severinghaus-type TcPCO2 electrode combined with a Clark-type TcPO2 electrode, with values per second for TcPO2, TcPCO2 in kPa and heat effect measured in units of mW. The sensor temperature will automatically be heated to 43.5℃ and calibrated. The sensor membrane will be changed every 28th day. There will be a 20-minute stabilization period from patient setup to valid data capturing. The use of sensors and monitors will be according to the manufacturer's instructions.
As a supplement, patients will be wearing an Empatica, as a measurement for the activity of the autonomic nervous system. The Empatica tracks activity, heartrate, blood volume pulse, skin temper-ature and skin conductance. The Empatica E4 consist of a PPG sensor and an EDA sensor. Data from the E4 will be processed in further studies and is not a part of the statistical analysis in this protocol.
Statistics The primary analysis is changes in TCM readings, and the association between clinical procedures, tested using paired statistics comparing both average (mean) TcPO2 and TcPCO2 during 5 minutes before an intervention versus 5 minutes after an intervention. Depending on the data distribution, either t-test or Wilcoxon test will be used.
Secondary analysis includes:
- Changes in TCM and association with specific intervention including grouping into circulatory and respiratory groups.
- Agreement between TcPO2 and PaO2, TcPCO2 and PaCO2. Agreement between the two tech-niques will be assessed using Bland-Altmann analysis including description of mean differ-ence and limits of agreement(17). In case of left-skewed data, log transformation will be ap-plied. A four-quadrant plot will be constructed to assess trending ability and a concordance rate will be calculated.
Tertiary analysis includes:
- An ANCOVA (analyses of co-variance) of the primary and secondary outcomes, with the following predefined variables: age, sex, BMI, ASA-score, and comorbidity, baseline labora-tory data (hemoglobin and creatinine).
- Agreement between perfusion-index and TCM. Agreement between the two techniques will be assessed using Bland-Altmann analysis including description of mean difference and limits of agreement. In case of left-skewed data, log transformation will be applied. A four-quadrant plot will be constructed to assess trending ability and a concordance rate will be calculated.
All results will be stated with their 95% confidence interval (CI). The significance level will be 5%, meaning p-values under 0.05 will be acknowledged as statistically significant. All analyses will be performed using Python 3.7 and the software program PyCharm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients undergoing major abdominal, urological, vascular, or orthope-dic surgery.
Key inclusion criteria (1 listed)
- A scheduled stay at PACU for at least 3 postoperatively.
Key exclusion criteria (1 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark)Patients undergo 2-3 hrs of observation while wearing the device. | Device | – |
Primary outcome
TCM changes
Time frame: 31-08-21
The primary outcome is changes in TCM recordings before and after clinical interventions and/or acute severe adverse events.
1 secondary outcome
ABG and TCM
Time frame: 31-08-21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Derived from this study: PubMed 36808596Thy SA, Johansen AO, Thy A, Sorensen HH, Molgaard J, Foss NB, Toft P, Meyhoff CS, Aasvang EK. Associations between clinical interventions and transcutaneous blood gas values in postoperative patients. J Clin Monit Comput. 2023 Oct;37(5):1255-1264. doi: 10.1007/s10877-023-00982-x. Epub 2023 Feb 18.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Anesthesia Care Optimaization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM changes (time frame: 31-08-21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.