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Completed

NCT Number: NCT03226041

PTCCO2 Monitoring During 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.

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Key information

Conditions

Transcutaneous Carbon Dioxide Partial Pressure Monitoring Retroperitoneoscopic Urologic Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.