Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 2402 for:    CARBON DIOXIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03508791
Recruitment Status : Not yet recruiting
First Posted : April 26, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

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
Ventilation Perfusion Mismatch Other: Arterial carbon dioxide monitoring Other: End-tidal carbon dioxide monitoring Other: Transcutaneous carbon dioxide monitoring Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 20, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Difference between arterial and end-tidal carbon dioxide pressures [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508791


Contacts
Layout table for location contacts
Contact: Jin-Young Hwang, MD.Ph.D. 82-2-870-2518 mistyblue15@naver.com

Sponsors and Collaborators
SMG-SNU Boramae Medical Center

Layout table for additonal information
Responsible Party: Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03508791     History of Changes
Other Study ID Numbers: 201804-1
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No