Transcutaneous Carbon Dioxide Partial Pressure MonitoringNCT03226041
PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery
A study testing transcutaneous monitor (TCM-4 monitor) in people with Transcutaneous Carbon Dioxide Partial Pressure Monitoring and Retroperitoneoscopic Urologic Surgery, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic renal or adrenal surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transcutaneous Carbon Dioxide Partial Pressure Monitoring, Retroperitoneoscopic Urologic Surgery
- What is being tested?
- transcutaneous monitor (TCM-4 monitor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing retroperitoneoscopic renal or adrenal surgery
- Age more than 16 years.
Who cannot join
- Care taker unable or unwilling to give oral informed consent
- Patients with history of severe trauma, operations, smoking, and severe cardiovascular or respiratory diseases, such as coronary heart disease, congestive heart failure, or chronic obstructive pulmonary disease
- 4.Subject has a condition or allergy which would prohibit placing the probe 5.Subject has participated in a trial with any experimental drug or device trial within 30 days prior to enrollment in the study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Application of Transcutaneous CO2 Partial Pressure Monitoring in the Anesthesia of Patients Undergoing Retroperitoneoscopic Urologic Surgery
To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic renal or adrenal surgery.
Read the detailed description
30 patients undergoing retroperitoneoscopic renal or adrenal surgery were included in this study.Their PaCO2, PetCO2, and PTCCO2values were measured at 3 time points before and 30min, 60min after pneumoperitoneum and calculated the different between each measure(PetCO2 and PTCCO2) and PaCO2. Agreement among measures was assessed by the Bland-Altman method.
- Conditions
- Transcutaneous Carbon Dioxide Partial Pressure Monitoring, Retroperitoneoscopic Urologic Surgery
- Being tested
- transcutaneous monitor (TCM-4 monitor)
- Keywords
- transcutaneous carbon dioxide, retroperitoneoscopic, urologic surgery, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous monitor (TCM-4 monitor)Device
TCM-4 monitor, which had changed new electrode membrane and was calibrated by the same person(who had been trained systematically) before each placement. The electrode should be heated to 44℃, then fixed it to the anterior part of chest in the location of lateral position after remove grease by alcohol. The positon of electrode must be changed every 2 hours in order to avoid thermal injury, and should be calibrated again.
| Study group | Role | What they receive |
|---|---|---|
| retroperitoneoscopic urologic surgery | Experimental | All included patients will undergo retroperitoneoscopic renal or adrenal surgery with the transcutaneous carbon dioxide monitor. Receives: Device: transcutaneous monitor (TCM-4 monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias and precision of the transcutaneous carbon dioxide measurements
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
Measured: 0 minutes(baseline)
Bias and precision of the transcutaneous carbon dioxide measurements
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
Measured: 30 minutes
Bias and precision of the transcutaneous carbon dioxide measurements
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
Measured: 60 minutes
Secondary outcomes (3)
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage
Measured: 0 minutes(baseline)
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage
Measured: 30 minutes
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Jul 2017
- Primary completion20 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Carbon Dioxide Partial Pressure MonitoringStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shijiang Liu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226041
- Sponsor's protocol ID
- 2016-SR-108
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Transcutaneous CO2 Partial Pressure Monitoring in the Anesthesia of Patients Undergoing Retroperitoneoscopic Urologic Surgery
- ClinicalTrials.gov ID
- NCT03226041
- Acronym / sponsor ID
- 2016-SR-108
- Conditions
- Transcutaneous Carbon Dioxide Partial Pressure Monitoring, Retroperitoneoscopic Urologic Surgery
- Keywords
- transcutaneous carbon dioxide, retroperitoneoscopic, urologic surgery, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jul 2017 (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.
To investigate the accuracy and correlation of estimating arterial CO2 pressure（PaCO2） using a transcutaneous CO2 pressure（PTCCO2） monitor in patients undergoing retroperitoneoscopic renal or adrenal surgery.
Detailed description
30 patients undergoing retroperitoneoscopic renal or adrenal surgery were included in this study.Their PaCO2, PetCO2, and PTCCO2values were measured at 3 time points before and 30min, 60min after pneumoperitoneum and calculated the different between each measure(PetCO2 and PTCCO2) and PaCO2. Agreement among measures was assessed by the Bland-Altman method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retroperitoneoscopic urologic surgery | Experimental | Device: transcutaneous monitor (TCM-4 monitor)All included patients will undergo retroperitoneoscopic renal or adrenal surgery with the transcutaneous carbon dioxide monitor. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing retroperitoneoscopic renal or adrenal surgery
- Age more than 16 years.
Key exclusion criteria (3 listed)
- Care taker unable or unwilling to give oral informed consent
- Patients with history of severe trauma, operations, smoking, and severe cardiovascular or respiratory diseases, such as coronary heart disease, congestive heart failure, or chronic obstructive pulmonary disease
- 4.Subject has a condition or allergy which would prohibit placing the probe 5.Subject has participated in a trial with any experimental drug or device trial within 30 days prior to enrollment in the study
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 |
|---|---|---|
| transcutaneous monitor (TCM-4 monitor)TCM-4 monitor, which had changed new electrode membrane and was calibrated by the same person(who had been trained systematically) before each placement. The electrode should be heated to 44℃, then fixed it to the anterior part of chest in the location of lateral position after remove grease by alcohol. The positon of electrode must be changed every 2 hours in order to avoid thermal injury, and should be calibrated again. | Device | retroperitoneoscopic urologic surgery |
Primary outcome
Bias and precision of the transcutaneous carbon dioxide measurements
Time frame: 0 minutes(baseline)
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
Bias and precision of the transcutaneous carbon dioxide measurements
Time frame: 30 minutes
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
Bias and precision of the transcutaneous carbon dioxide measurements
Time frame: 60 minutes
correlation and agreement between PetCO2 and PaCO2 and PTCCO2
3 secondary outcomes
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
Time frame: 0 minutes(baseline)
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
Time frame: 30 minutes
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )
Time frame: 60 minutes
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 7 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Shijiang Liu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous monitor (TCM-4 monitor) in people with Transcutaneous Carbon Dioxide Partial Pressure Monitoring and Retroperitoneoscopic Urologic Surgery, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 2 inclusion and 3 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 7 Jul 2020. 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 China. 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?
Bias and precision of the transcutaneous carbon dioxide measurements (time frame: 0 minutes(baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2020.