Modeling the Effect of EtCO2 on Cerebral Oxygenation
Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia
1 other identifier
interventional
55
1 country
1
Brief Summary
The aim of this study was to investigate the relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 12, 2015
February 1, 2015
3 months
October 20, 2014
February 10, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
The parameters of indirect response model
fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2
60 min
The factors that influence the model parameters
mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight
60 min
Study Arms (1)
Change of EtCO2
EXPERIMENTALChanges of rSO2 after adjustment of EtCO2 between 27-45 mmHg
Interventions
Initial data collection during BCP was performed following three conditions were satisfied: after start of surgery; at least 15 min after BCP (for stabilization of MAP); after ventilation frequency was adjusted to produce EtCO2 of 27-29 mmHg with tidal volume of 8 ml/kg. Data was collected every 3 min after decreasing ventilation frequency by 1-2 breaths/min to increase EtCO2 until 42-45 mmHg. Once the value of EtCO2 42-45 mmHg was reached, ventilator frequency was increased in the same way to decrease EtCO2 until 27-29 mmHg. Fraction of inspired oxygen of 50% was maintained and end-tidal desflurane concentration was adjusted to achieve bispectral index values of 40-55 during data collection.
Eligibility Criteria
You may qualify if:
- Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia
You may not qualify if:
- Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Woo Han, MD, PhD
Severance Hospital, Yonsei University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
October 20, 2014
First Posted
November 6, 2014
Study Start
October 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 12, 2015
Record last verified: 2015-02