Status:
WITHDRAWN
CirQPOD Shoulder Study
Lead Sponsor:
Zoll Medical Corporation
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Hypotension on Induction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood p...
Eligibility Criteria
Inclusion
- Age ≥18 years
- American Society of Anesthesiologists (ASA) physical status class ≤3
- Scheduled for surgery in sitting/ beach-chair positions under general anesthesia in the Cleveland Clinic main campus
- Planned length of surgery \>60 minutes
Exclusion
- Severe peripheral vascular disease or other contraindication for use of vasopressor infusion
- Obstructive lung disease - moderate or severe asthma or COPD
- Baseline hypoxemia (SpO2\<92% on room air)
- Body Mass Index (BMI) \>35
- Congestive heart failure
- Pneumothorax or hemothorax
- Uncontrolled hemorrhage
- Planned intraoperative hypotension
- Contraindication to trans-esophageal echocardiography (esophageal stricture, surgery involving the esophagus or stomach)
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04299776
Start Date
January 28 2020
End Date
March 28 2020
Last Update
January 27 2022
Active Locations (1)
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1
Outcomes Research, Anesthesia Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195