PTCCO2 Monitoring During Retroperitoneoscopic Urologic Surgery

Retroperitoneoscopic Urologic Surgery Clinical Trial

Official title:

The Application of Transcutaneous CO2 Partial Pressure Monitoring in the Anesthesia of Patients Undergoing Retroperitoneoscopic Urologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226041
• Other study ID #: 2016-SR-108
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2020
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retroperitoneoscopic Urologic Surgery
• Transcutaneous Carbon Dioxide Partial Pressure Monitoring

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	0 minutes(baseline)
Primary	Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	30 minutes
Primary	Bias and precision of the transcutaneous carbon dioxide measurements	correlation and agreement between PetCO2 and PaCO2 and PTCCO2	60 minutes
Secondary	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)
Secondary	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
Secondary	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