Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide

NCT03508791 — Not applicable, Unknown, 142 participants, SMG-SNU Boramae Medical Center

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Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery

Registry	NCT03508791
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: double, other
Enrollment	142 (Estimated)
Sponsor	SMG-SNU Boramae Medical Center (Other)
Conditions	Ventilation Perfusion Mismatch
Interventions	Arterial carbon dioxide monitoring, End-tidal carbon dioxide monitoring, Transcutaneous carbon dioxide monitoring (Other)
Dates	start 2018-05-20 (estimated), primary completion 2019-04-01 (estimated), completion 2019-04-01 (estimated), first posted 2018-04-26, last updated 2018-05-01

-Summary

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Trendelenburg group	Active comparator	Other: Arterial carbon dioxide monitoring; Other: End-tidal carbon dioxide monitoring; Other: Transcutaneous carbon dioxide monitoring	Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position
reverse Trendelenburg group	Active comparator	Other: Arterial carbon dioxide monitoring; Other: End-tidal carbon dioxide monitoring; Other: Transcutaneous carbon dioxide monitoring	Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position

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

+Outcome measures

Primary outcomes

Difference between arterial and end-tidal carbon dioxide pressures [baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2]: Difference between arterial and end-tidal carbon dioxide partial pressures are calculated. (Arterial carbon dioxide partial pressure minus end-tidal carbon dioxide partial pressure)

Secondary outcomes

Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure [baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2]: Arterial, end-tidal, and transcutaneous carbon dioxide partial pressures are recorded and the agreement among the values is analyzed using the statistical test.

+Eligibility

Sex: All, ages: 20 Years to any

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

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