Rapid Treatment of Shock Without Trauma

NCT05073354 | Completed FDA Device

• 1 other identifier: 50701
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the implementation of a standardized mobile resuscitation model to manage SWOT within a large acute care hospital setting.

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

• Time to Shock Reversal

  Duration in minutes from activation of the SWOT Team to shock reversal, defined as stable arterial pressure (SBP \> 90 mmHg) without requirement for vasopressor administration for greater than 24 hours and normalization of systemic and local perfusion measures of lab-measured lactate indicating improved systemic perfusion

  From 24 hours to 72 hours after initial shock event

Secondary Outcomes (1)

• 30-day Mortality

  30 days after initial shock event

Study Arms (1)

Full-implementation

Patients experiencing shock without trauma once all training is in place and devices are deployed

Device: Full SWOT Model

Interventions

Full SWOT Model DEVICE

Bundle of care that includes devices such as X Series monitor/defibrillator, AutoPusle automated compression device, Z Vent ventilator, and IPR therapies as well as bedside monitoring and diagnostics and training on a standardized care process.

Full-implementation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting all enrollment criteria will be eligible for enrollment in the study.

You may qualify if:

• to 75 years of age (inclusive)
• Presence of shock, defined as systolic blood pressure (SBP) less than 90 mmHg with signs of hypoperfusion, including at least one of the following (without alternate causes):
• low cardiac index (\<2.2 L/min/m2)
• elevated filling pressures of the left heart (pulmonary capillary wedge pressure \[PCWP\] \>15 mmHg) and/or
• right heart (central venous pressure \[CVP\] \>10 mmHg)
• non-perfusing cardiac rhythm or cardiac arrest
• mixed venous oxygen saturation \<60% or \>80% without non-shock cause
• Heart rate \>90 beats per minute
• Respiratory rate \>20 breaths per minute
• White blood cell count \>12 or \< 4
• Temperature \>38°C or \<35°C
• SOFA score ≥2 with vasopressor requirement and elevated lactate \>2 mmol/L (\>18 mg/dL) despite adequate fluid resuscitation
• Central venous pressure \<8 mmHg
• Obstruction such as pulmonary embolus on imaging
• Admitted to Abbott Northwestern

You may not qualify if:

• Known or suspected pregnancy
• Significant trauma
• BMI \> 50 kg/m2
• Pre-existing Do Not Resuscitate order
• Presence of orders limiting resuscitation efforts during the initial resuscitative period (less than 2 hours from the onset of protocol)
• Refusal to receive whole blood or blood products
• Severe brain injury (anoxic, traumatic, hemorrhagic or ischemic)
• presence of an assist device such as intra-aortic balloon pump
• Advanced chronic organ dysfunction
• Known or presumed COVID-19
• Patients with a status of MRA "No"
• Patient in ICU at time of shock
• Candidates for the prospective case series will be excluded if the following condition is present:
• Patients with a status of MRA "No"
• Patient in ICU at time of shock

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonia M Mowbray-Donahue, MD

  Allina Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 11, 2021
• Study Start: June 29, 2021
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)