CirQPOD Shoulder Study

Hypotension on Induction Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04299776
• Other study ID #: 40701
• Status: Withdrawn
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: March 28, 2020

Study information

• Verified date: January 2022
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

Intervention

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

Locations

Country	Name	City	State
United States	Outcomes Research, Anesthesia Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Zoll Medical Corporation	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Atelectasis	presence and amount of atelectasis as determined by chest computerized tomography (CT)	first day post-op
Secondary	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