PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery

Not Applicable

Completed

• Conditions: Transcutaneous Carbon Dioxide Partial Pressure Monitoring; Retroperitoneoscopic Urologic Surgery

• Registration Number: NCT03226041
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

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 Timeline

• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-19
• Study Start: 2017-07-20
• Study First Posted: 2017-07-21
• Primary Completion: 2019-11-20
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Bias and precision of the transcutaneous carbon dioxide measurements	60 minutes	correlation and agreement between PetCO2 and PaCO2 and PTCCO2

Secondary Outcome Measures

Name	Time	Method
complication: appearance of signs of thermal injury (redness, skin erythema, blisters, necrosis) under application of transcutaneous sensor temperatures of 44°C )	60 minutes	While the sensor temperatures heated to 44°C, the skin will be closely observed for any kind of thermic tissue damage

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China