Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide
1 other identifier
interventional
142
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedStudy Start
First participant enrolled
May 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMay 1, 2018
April 1, 2018
11 months
April 20, 2018
April 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Difference between arterial and end-tidal carbon dioxide pressures
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 Outcomes (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
Study Arms (2)
Trendelenburg group
ACTIVE COMPARATORArterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the Trendelenberg position
reverse Trendelenburg group
ACTIVE COMPARATORArterial, end-tidal, and transcutaneous carbon dioxide partial pressure are monitored in the reverse Trendelenberg position
Interventions
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.
Eligibility Criteria
You may qualify if:
- adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum \> 1 hour) in the Trendelenburg or reverse Trendelenburg positions
You may not qualify if:
- hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.
- symptomatic pulmonary disease, chronic obstructive pulmonary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 20, 2018
First Posted
April 26, 2018
Study Start
May 20, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
May 1, 2018
Record last verified: 2018-04