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Trial record 1 of 683 for:    CARBON DIOXIDE AND arterial
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Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide

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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

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date May 1, 2018
Estimated Study Start Date  ICMJE May 20, 2018
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Difference between arterial and end-tidal carbon dioxide pressures [ Time Frame: every 30 minute during laparoscopic surgery ]
Difference between arterial and end-tidal carbon dioxide partial pressures are calculated. (Arterial carbon dioxide partial pressure minus end-tidal carbon dioxide partial pressure)
Change History Complete list of historical versions of study NCT03508791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Agreement among arterial, end-tidal, and transcutaneous carbon dioxide partial pressure [ Time Frame: every 30 minute during laparoscopic surgery ]
Arterial, end-tidal, and transcutaneous carbon dioxide partial pressures are recorded and the agreement among the values is analyzed using the statistical test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide
Official Title  ICMJE Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Ventilation Perfusion Mismatch
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Trendelenburg group
    Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position
    Interventions:
    • Other: Arterial carbon dioxide monitoring
    • Other: End-tidal carbon dioxide monitoring
    • Other: Transcutaneous carbon dioxide monitoring
  • Active Comparator: reverse Trendelenburg group
    Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position
    Interventions:
    • Other: Arterial carbon dioxide monitoring
    • Other: End-tidal carbon dioxide monitoring
    • Other: Transcutaneous carbon dioxide monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2018)
142
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jin-Young Hwang, MD.Ph.D. 82-2-870-2518 mistyblue15@naver.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508791
Other Study ID Numbers  ICMJE 201804-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin-Young Hwang, SMG-SNU Boramae Medical Center
Study Sponsor  ICMJE SMG-SNU Boramae Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SMG-SNU Boramae Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP