NCT02643030

Brief Summary

The purpose of this study is to evaluate the effects of hypercapnia on hemodynamics and cerebral oxygenation during shoulder arthroscopy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Status
completed

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

March 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.5 years

First QC Date

December 23, 2015

Last Update Submit

December 28, 2015

Conditions

Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

  • Regional cerebral oxygen saturation

    Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position

Study Arms (2)

normocapnia

EXPERIMENTAL

Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

Behavioral: normocapnia

hypercapnia

ACTIVE COMPARATOR

Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg

Behavioral: hypercapnia

Interventions

hypercapniaBEHAVIORAL

Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg

Also known as: ETCO2-45
hypercapnia
normocapniaBEHAVIORAL

Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg

Also known as: ETCO2-35
normocapnia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective shoulder arthroscopic surgery

You may not qualify if:

  • a history of age \> 65 years, morbidly obesity (BMI \> 30 kg/m2), diffuse lung disease, uncontrolled systemic hypertension, intracranial disease, cardiovascular and cerebrovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pohl A, Cullen DJ. Cerebral ischemia during shoulder surgery in the upright position: a case series. J Clin Anesth. 2005 Sep;17(6):463-9. doi: 10.1016/j.jclinane.2004.09.012.

    PMID: 16171668RESULT

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kyung Cheon Lee, MD

    Gachon University Gil Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 23, 2015

First Posted

December 30, 2015

Study Start

March 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12