A Randomized Clinical Trial on the Effects of Active Intrathoracic Pressure Regulation Therapy on Hemodynamic Stability During Shoulder Surgery in the Sitting Position
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension on Induction
- Sponsor
- Zoll Medical Corporation
- Locations
- 1
- Primary Endpoint
- Phenylephrine use
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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 pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications.
The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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)
Outcomes
Primary Outcomes
Phenylephrine use
Time Frame: from device placement to start of wound closure, a period of up to four hours
Amount of phenylephrine required to maintain MAP of 80±5 mmHg
Secondary Outcomes
- Pulmonary artery pressure(at least two minutes after IPR level of -10 cmH2O has been set)
- Atelectasis(first day post-op)
- PaO2(at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation)