CirQPOD Shoulder Study

NCT04299776 | Withdrawn FDA Device

• 1 other identifier: 40701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension on Induction

Keywords

Intraoperative hypotension

Outcome Measures

Primary Outcomes (1)

• Phenylephrine use

  Amount of phenylephrine required to maintain MAP of 80±5 mmHg

  from device placement to start of wound closure, a period of up to four hours

Secondary Outcomes (3)

• 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 Arms (2)

IPR therapy

EXPERIMENTAL

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

Device: CirQPOD

Standard airway

ACTIVE COMPARATOR

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

Device: Standard airway management

Interventions

CirQPOD 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.

IPR therapy

Standard airway management DEVICE

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

Standard airway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zoll Medical Corporation: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Outcomes Research, Anesthesia Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 9, 2020
• Study Start: January 28, 2020
• Primary Completion: March 28, 2020
• Study Completion: March 28, 2020
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)