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Clinical Trials/NCT04299776
NCT04299776
Withdrawn
Not Applicable

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

Zoll Medical Corporation1 site in 1 countryJanuary 28, 2020

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
January 28, 2020
End Date
March 28, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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