CirQPOD Shoulder Study

Not Applicable

Withdrawn

• Conditions: Hypotension on Induction
• Interventions: Device: CirQPOD; Device: Standard airway management

• Registration Number: NCT04299776
• Lead Sponsor: Zoll Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-09
• Primary Completion: 2020-03-28
• Study Completion: 2020-03-28
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPR therapy	CirQPOD	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
Standard airway	Standard airway management	Standard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position

Primary Outcome Measures

Name	Time	Method
Phenylephrine use	from device placement to start of wound closure, a period of up to four hours	Amount of phenylephrine required to maintain MAP of 80±5 mmHg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Outcomes Research, Anesthesia Institute, Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States