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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03508791
Other study ID # 201804-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2018
Est. completion date April 2019

Study information

Verified date April 2018
Source SMG-SNU Boramae Medical Center
Contact Jin-Young Hwang, MD.Ph.D.
Phone 82-2-870-2518
Email mistyblue15@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery.


Description:

Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Arterial carbon dioxide partial pressure is assessed intermittently before, during, and after pneumoperitoneum. End-tidal and transcutaneous carbon dioxide partial pressure are continuously monitored.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 142
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum > 1 hour) in the Trendelenburg or reverse Trendelenburg positions

Exclusion Criteria:

- hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.

- symptomatic pulmonary disease, chronic obstructive pulmonary disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Arterial carbon dioxide monitoring
Arterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
End-tidal carbon dioxide monitoring
End-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
Transcutaneous carbon dioxide monitoring
Transcutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
SMG-SNU Boramae Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Difference between arterial and end-tidal carbon dioxide pressures Difference between arterial and end-tidal carbon dioxide partial pressures are calculated. (Arterial carbon dioxide partial pressure minus end-tidal carbon dioxide partial pressure) baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
Secondary Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure Arterial, end-tidal, and transcutaneous carbon dioxide partial pressures are recorded and the agreement among the values is analyzed using the statistical test. baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
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