CirQPOD Shoulder Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-03-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension on Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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IPR therapy

Intrathoracic pressure regulation (IPR) therapy level of -10 cmH2O (-7 cmH2O for run-in) provided by the CirQPOD device during shoulder surgery in the sitting position

Group Type EXPERIMENTAL

CirQPOD

Intervention Type DEVICE

CirQPOD is connected between the wye piece on ventilator/anesthesia machine tubing and the patient's airway and generates negative intrathoracic pressure during the expiratory phase of ventilation which has been shown to improve blood flow.

Standard airway

Standard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position

Group Type ACTIVE_COMPARATOR

Standard airway management

Intervention Type DEVICE

Standard airway management during surgery (PEEP of +5 cmH2O)

Interventions

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CirQPOD

CirQPOD is connected between the wye piece on ventilator/anesthesia machine tubing and the patient's airway and generates negative intrathoracic pressure during the expiratory phase of ventilation which has been shown to improve blood flow.

Intervention Type DEVICE

Standard airway management

Standard airway management during surgery (PEEP of +5 cmH2O)

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No