The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01546636
First received: March 2, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The aim of this clinical investigation is to determine the effect of intraoperative ventilation on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery in the beach chair position (BCP)


Condition Intervention Phase
Cerebral Ischemia
Other: Hypocapnic group
Other: Normocapnic group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Incidence of Cerebral Desaturation Events [ Time Frame: Intraoperative-first 2 hours ] [ Designated as safety issue: Yes ]
    Cerebral desaturation events were measured with near-infrared spectroscopy


Secondary Outcome Measures:
  • Number of Patients Experiencing Nausea and Vomiting [ Time Frame: Postanesthesia care unit-first 2 hours ] [ Designated as safety issue: No ]
    Assessed by recovery nurses

  • Postanesthesia Care Unit Length of Stay (Total Time) [ Time Frame: Approximately 5 hours ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: November 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Other: Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
Other Name: Hypocapnic group
Active Comparator: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Other: Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg
Other Name: Normocapnic group

Detailed Description:

Recent developments in near-infrared spectroscopy technology now permit rapid assessment of cerebral oxygenation (SctO2) using non-invasive probes. A high incidence cerebral desaturation events (CDE-defined as a decrease in SctO2 values below 20% of baseline measures or absolute SctO2 values ≤ 55 for ≥ 15 seconds) have been observed in previous investigation of patients undergoing shoulder surgery in BCP with hyperventilation. The investigators hypothesize that the incidence of CDE will be reduced in patients ventilated at normocapnic levels (end-tidal carbon dioxide values (ETCO2) of 40-42 mm Hg) when compared to subjects hyperventilated (ETCO2 of 30-32 mm Hg) in the operating room. Patients undergoing shoulder surgery in the BCP will be randomized to a hypocapnic group (ETCO2 of 30-32 mm Hg) or a normocapnic group (ETCO2 of 40-42 mm Hg). Cerebral oxygenation will be measured continuously throughout the procedure to assess perioperative SctO2 values and the incidence of CDE. The investigators previously observed an association between CDE in the operating room and postoperative nausea and vomiting. Therefore, the effect of ventilatory pattern and intraoperative SctO2 on clinical recovery will also be determined.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting for elective shoulder arthroscopy under general anesthesia in the BCP.

Exclusion Criteria:

  • Exclusion criteria include 1) history of pre-existing cerebrovascular disease or orthostatic hypotension 2) age < 18 years 3) American Society of Anesthesiologists Physical Status IV or V.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546636

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
Principal Investigator: Glenn S. Murphy, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Glenn S. Murphy, MD, Director, Cardiac Anesthesia and Clinical Research, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01546636     History of Changes
Other Study ID Numbers: EH10-184
Study First Received: March 2, 2012
Results First Received: July 16, 2013
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
Cerebral desaturation events
Cerebral oximetry
Beach chair position

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014