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

Sponsor
SMG-SNU Boramae Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03508791
Collaborator
(none)
142
Enrollment
2
Arms
10.4
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arterial carbon dioxide monitoring
  • Other: End-tidal carbon dioxide monitoring
  • Other: Transcutaneous carbon dioxide monitoring
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
142 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
Anticipated Study Start Date :
May 20, 2018
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Trendelenburg group

Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position

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

Other: 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.

Other: Transcutaneous carbon dioxide monitoring
Transcutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
Active Comparator: reverse Trendelenburg group

Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position

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

Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SMG-SNU Boramae Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier:
NCT03508791
Other Study ID Numbers:
  • 201804-1
First Posted:
Apr 26, 2018
Last Update Posted:
May 1, 2018
Last Verified:
Apr 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 1, 2018