CirQPOD Shoulder Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypotension on Induction
• Intervention / Treatment: Device: CirQPOD; Device: Standard airway management

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Outcomes Research, Anesthesia Institute, Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
Active Comparator: Standard airway; Standard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position	Device: Standard airway management; Standard airway management during surgery (PEEP of +5 cmH2O)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary artery pressure	pressure in the pulmonary artery as measured by transesophageal echocardiography (TEE)	at least two minutes after IPR level of -10 cmH2O has been set
Atelectasis	presence and amount of atelectasis as determined by chest computerized tomography (CT)	first day post-op
PaO2	post-operative partial arterial oxygen pressure measured by arterial blood gas (ABG)	at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Collaborators: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): March 28, 2020
• Study Completion (Actual): March 28, 2020

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Intraoperative hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 40701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No