PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Transcutaneous Carbon Dioxide Partial Pressure Monitoring; Retroperitoneoscopic Urologic Surgery
• Intervention / Treatment: Device: transcutaneous monitor (TCM-4 monitor)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	0 minutes(baseline)
Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	30 minutes
Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	60 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ACTUAL): November 20, 2019
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: anesthesia; transcutaneous carbon dioxide; urologic surgery; retroperitoneoscopic
• Other Study ID Numbers: 2016-SR-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No