Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04735380 |
| Other study ID # |
P-2020-1159 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Sandra Amalie Thy |
| Phone |
+4526991622 |
| Email |
sandra.amalie.thy[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. The secondary aim is to
describe the agreement between TcPO2 and TcPCO2 and PaO2 and PaCO2 in patients after
non-cardiac surgery.
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.
