CirQPOD Shoulder Study

Study 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.

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

Conditions
-----------------
Hypotension on Induction

Intervention / Treatment
-----------------
* Device: CirQPOD
* Device: Standard airway management


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPR therapy<br>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<br>* 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.<br>|
| Active Comparator: Standard airway<br>Standard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position | Device: Standard airway management<br>* Standard airway management during surgery (PEEP of +5 cmH2O)<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intraoperative hypotension