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PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery

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ClinicalTrials.gov Identifier: NCT03226041
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Transcutaneous Carbon Dioxide Partial Pressure Monitoring Retroperitoneoscopic Urologic Surgery Device: transcutaneous monitor (TCM-4 monitor) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Application of Transcutaneous CO2 Partial Pressure Monitoring in the Anesthesia of Patients Undergoing Retroperitoneoscopic Urologic Surgery
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : June 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: retroperitoneoscopic urologic surgery
All included patients will undergo retroperitoneoscopic renal or adrenal surgery with the transcutaneous carbon dioxide monitor.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Bias and precision of the transcutaneous carbon dioxide measurements [ Time Frame: 0 minutes(baseline) ]
    correlation and agreement between PetCO2 and PaCO2 and PTCCO2

  2. Bias and precision of the transcutaneous carbon dioxide measurements [ Time Frame: 30 minutes ]
    correlation and agreement between PetCO2 and PaCO2 and PTCCO2

  3. Bias and precision of the transcutaneous carbon dioxide measurements [ Time Frame: 60 minutes ]
    correlation and agreement between PetCO2 and PaCO2 and PTCCO2


Secondary Outcome Measures :
  1. 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) ]
    While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage

  2. 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 ]
    While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage

  3. 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 ]
    While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients undergoing retroperitoneoscopic renal or adrenal surgery
  2. Age more than 16 years.

Exclusion Criteria:

  1. Care taker unable or unwilling to give oral informed consent
  2. 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

Contacts and Locations
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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): NCT03226041


Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Shijiang Liu The First Affiliated Hospital with Nanjing Medical University
More Information
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03226041    
Other Study ID Numbers: 2016-SR-108
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
transcutaneous carbon dioxide
retroperitoneoscopic
urologic surgery
anesthesia