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Modeling the Effect of EtCO2 on Cerebral Oxygenation

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ClinicalTrials.gov Identifier: NCT02284763
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Shoulder Surgery Other: EtCO2 Not Applicable

Detailed Description:
Even though mild hypercapnia in the beach chair position (BCP) under general anesthesia was effective in reducing cerebral desaturation, there is no comprehensive data with regard to the dose-effect relationship of EtCO2 on rSO2 in the BCP under general anesthesia. Pharmacodynamic modeling can be useful in describing this relationship in which concurrent mean arterial pressure changes and disease state can be considered as covariates. Therefore, we investigated the relationship between the EtCO2 and rSO2 and identified the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Change of EtCO2
Changes of rSO2 after adjustment of EtCO2 between 27-45 mmHg
Other: EtCO2
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.




Primary Outcome Measures :
  1. The parameters of indirect response model [ Time Frame: 60 min ]
    fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2

  2. The factors that influence the model parameters [ Time Frame: 60 min ]
    mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia

Exclusion Criteria:

  • Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V

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): NCT02284763


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
Investigators
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Principal Investigator: Dong Woo Han, MD, PhD Severance Hospital, Yonsei University College of Medicine

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Responsible Party: So Yeon Kim, Assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT02284763    
Other Study ID Numbers: 4-2014-0688
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015