ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypercapnia During Shoulder Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02643030
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Cerebral Ischemia Behavioral: hypercapnia Behavioral: normocapnia Not Applicable

Detailed Description:
The patients are randomly allocated to receive normocapnia or hypercapnia . After the 70º sitting position, record the mean arterial pressure (MAP), heart rate, and regional oxygen saturation (rSO2).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Hypercapnia on Regional Cerebral Oxygen Saturation in the Sitting Position
Study Start Date : March 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: normocapnia
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Behavioral: normocapnia
Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
Other Name: ETCO2-35

Active Comparator: hypercapnia
Tidal volume (6ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Behavioral: hypercapnia
Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
Other Name: ETCO2-45




Primary Outcome Measures :
  1. Regional cerebral oxygen saturation [ Time Frame: Change from Regional cerebral oxygen saturation at 2,4,6,8,10,20 min after anesthetic induction and sitting position ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing elective shoulder arthroscopic surgery

Exclusion Criteria:

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

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): NCT02643030


Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Chair: Kyung Cheon Lee, MD Gachon University Gil Medical Center

Publications of Results:
Responsible Party: Youn Yi Jo, Assistant professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02643030     History of Changes
Other Study ID Numbers: GIRBA2674-2012
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Ischemia
Hypercapnia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke