The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Cerebral Ischemia Clinical Trial

Official title:

The Effect of Ventilation on Cerebral Oxygenation in the Sitting Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546636
• Other study ID #: EH10-184
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia

Intervention

Other:
• Hypocapnic group
Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
• Normocapnic group
Patients will be ventilated to an ETCO2 of 40-42 mm Hg

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Cerebral Desaturation Events	Cerebral desaturation events were measured with near-infrared spectroscopy	Intraoperative-first 2 hours
Secondary	Number of Patients Experiencing Nausea and Vomiting	Assessed by recovery nurses	Postanesthesia care unit-first 2 hours
Secondary	Postanesthesia Care Unit Length of Stay (Total Time)		Approximately 5 hours