Clinical trial NCT04299776: CirQPOD Shoulder Study
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypotension on Induction
Keywords: Intraoperative hypotension
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2020-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Phenylephrine use
timeFrame: from device placement to start of wound closure, a period of up to four hours
Secondary outcomes:
measure: Pulmonary artery pressure
timeFrame: at least two minutes after IPR level of -10 cmH2O has been set
measure: Atelectasis
timeFrame: first day post-op
measure: PaO2
timeFrame: at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Outcomes Research, Anesthesia Institute, Cleveland Clinic
state: Ohio
Study officials:
References: