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CompletedNCT02284763Updated Feb 12, 2015

Modeling the Effect of EtCO2 on Cerebral Oxygenation

An interventional study of EtCO2 in Shoulder Surgery, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by Severance Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Shoulder Surgery
03

In context

Lead sponsor

Severance Hospital is the lead sponsor of 50 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Change of EtCO2

    Changes of rSO2 after adjustment of EtCO2 between 27-45 mmHg

    Other: EtCO2

Interventions

  • OtherEtCO2

    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.

06

What researchers measure

Primary outcomes

  1. The parameters of indirect response model

    fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2

    Time frame: 60 min

  2. The factors that influence the model parameters

    mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight

    Time frame: 60 min

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02284763
Lead sponsor
Severance Hospital
Responsible party
So Yeon Kim (Assistant professor, Severance Hospital) — Principal investigator
First posted
Nov 6, 2014
Start date
Oct 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Feb 12, 2015

Study contacts

Dong Woo Han, MD, PhD
principal investigator · Severance Hospital, Yonsei University College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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