CirQPOD Shoulder Study

Hypotension on Induction Clinical Trial

Official title: A Randomized Clinical Trial on the Effects of Active Intrathoracic Pressure Regulation Therapy on Hemodynamic Stability During Shoulder Surgery in the Sitting Position

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

• NCT number: NCT04299776
• Study type: Interventional
• Source: Zoll Medical Corporation
• Status: Withdrawn
• Phase: N/A
• Start date: January 28, 2020
• Completion date: March 28, 2020