Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04299776
Other study ID # 40701
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05497700 - Comparative Efficacity of Ephedrine Versus Norepinephrine to Correct Anesthesia Induction Related Hypotension Phase 3
Not yet recruiting NCT03580590 - Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery Early Phase 1
Completed NCT04573842 - Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Recruiting NCT06426784 - Perfusion Index as a Predictor of Hypotension Following Sub-arachnoid Block Among Patients Undergoing Lower Segment Caesarean Section
Completed NCT04603469 - Hypotension in Children With Down Syndrome With Anesthesia Induction
Recruiting NCT05891951 - Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery N/A
Completed NCT05842759 - Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study N/A
Recruiting NCT05884918 - Intraoperative Hypotension in High-risk Patients Undergoing Surgery
Completed NCT05239234 - Ultrasonographic Predictors of Hypotension After Induction
Not yet recruiting NCT04291794 - Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion Phase 4
Completed NCT04051073 - Can Continuous Non-invasive Monitoring Improve Stability of Intraoperative Blood Pressure - A Feasibility Study. Phase 3
Completed NCT01669434 - Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery Phase 4
Completed NCT05424510 - PoCUS Guided Fluids to Prevent Post-induction Hypotension N/A
Recruiting NCT05969886 - Ventricular-Arterial Coupling: A Predictor of Post-Induction Hypotension
Not yet recruiting NCT05536323 - Bolus Versus Continuous Remimazolam for Anesthetic Induction N/A
Recruiting NCT03237429 - The Relationship Between BCM, Arterial Stiffness and Hemodynamic Instability During Induction of General Anesthesia
Completed NCT03439007 - Anesthesia-induced Hypotension and Fluid Responsiveness
Completed NCT03787732 - Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation Phase 4
Not yet recruiting NCT05960604 - Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Completed NCT04658576 - Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension