- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508791
Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide
April 27, 2018 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide Partial Pressure in Patients Undergoing Laparoscopic Surgery
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.
Study Overview
Status
Unknown
Conditions
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
Interventional
Enrollment (Anticipated)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin-Young Hwang, MD.Ph.D.
- Phone Number: 82-2-870-2518
- Email: mistyblue15@naver.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Trendelenburg group
Arterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position
|
Arterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
End-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
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
|
Arterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
End-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
Transcutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline before CO2 pneumoperitoneum, every 30 minute during CO2 pneumoperitoneum, and 15 min after deflation of CO2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2018
Primary Completion (Anticipated)
April 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
April 24, 2018
First Posted (Actual)
April 26, 2018
Study Record Updates
Last Update Posted (Actual)
May 1, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 201804-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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