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SWOT: Rapid Treatment of Shock Without Trauma

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05073354
Collaborator
(none)
138
Enrollment
1
Location
23
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Full SWOT Model
  • Device: Partial SWOT Model
  • Other: Standard of Care

Detailed Description

Immediately upon identification of SWOT, the SWOT Team will be activated by clinicians to respond to the patient bedside. Clinicians on-site will initiate patient care as directed by hospital protocol. Upon arrival, the SWOT Team will take over the management of patient care. The team will include 1-2 intensivists and multiple clinicians with clearly defined roles, dependent upon clinical presentation. The mobile resuscitative platform equipped with critical care technology will be delivered to the bedside (refer to appendix for full equipment content).

The SWOT Team will implement goal-directed therapy using real-time monitoring and advanced diagnostic point-of-care tools. ultrasound, arterial and central lines will be placed by the intensivist(s) to monitor the physiology of the patient during treatment in real-time. Other team members (RNs, Respiratory Therapist's, residents, anesthesiologists, and technicians) will place the patient on continuous ECG and SPO2 monitoring, continuous capnographic monitoring via nasal canula or Endotracheal tube, and continuous cerebral and regional NIRS monitors. Point-of-care laboratory values will also be measured. Resuscitative interventions will be performed as directed by team leader to target the following physiological target parameters:

  • SpO2 > 85%

  • PaO2 > 50 mmHg

  • NIRS > 65%

  • Lactate normal or trending down

  • EtCO2 >20 mmHg

  • Mean Arterial Pressure > 65 mmHg

  • SVO2 > 60%

Study Design

Study Type:
Observational
Anticipated Enrollment :
138 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Implementation of a Mobile In-hospital Resuscitation Model for the Rapid Treatment of Shock Without Trauma (SWOT)
Actual Study Start Date :
Jun 29, 2021
Anticipated Primary Completion Date :
Apr 29, 2023
Anticipated Study Completion Date :
May 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Pre-implementation

Patients experiencing shock without trauma prior to any SWOT model training or devices

Other: Standard of Care
Standard of Care treatment to patients before development of SWOT protocol.
Partial-implementation

Patients experiencing shock without trauma after training and device deployment has been started but not fully implemented

Device: Partial SWOT Model
Historical control. Partial bundle of care that includes some bedside monitoring and diagnostics as well as training on a standardize care process
Full-implementation

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

Device: Full SWOT Model
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.

Outcome Measures

Primary Outcome Measures

  1. Time to Shock Reversal [From 24 hours to 72 hours after initial shock event]

    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

Secondary Outcome Measures

  1. 30-day Mortality [30 days after initial shock event]

    Patient all-cause mortality will be assessed at 30 days following initial identification of shock symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 18 to 75 years of age (inclusive)

  2. 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

  1. Admitted to Abbott Northwestern

  2. Rapid Response Team call or request

  3. Patients who previously agreed to allow their medical record information to be used for Allina Health research (i.e. Minnesota Research Authorization (MRA) "Yes") or those who have not explicitly declined use of their medical information in Allina Health research (i.e. MRA "Null")

Candidates for the prospective case series must meet the following inclusion criterion:

  1. Interventional assessment and treatment by SWOT Team (full-implementation period only)

  2. Patients who previously agreed to allow their medical record information to be used for Allina Health research (i.e. Minnesota Research Authorization (MRA) "Yes") or those who have not explicitly declined use of their medical information in Allina Health research (i.e. MRA "Null")

Exclusion Criteria:

  1. Known or suspected pregnancy

  2. Significant trauma

  3. BMI > 50 kg/m2

  4. Pre-existing Do Not Resuscitate order

  5. Presence of orders limiting resuscitation efforts during the initial resuscitative period (less than 2 hours from the onset of protocol)

  6. Refusal to receive whole blood or blood products

  7. Severe brain injury (anoxic, traumatic, hemorrhagic or ischemic)

  8. presence of an assist device such as intra-aortic balloon pump

  9. Advanced chronic organ dysfunction

  10. Known or presumed COVID-19

  11. Patients with a status of MRA "No"

  12. Patient in ICU at time of shock

Candidates for the prospective case series will be excluded if the following condition is present:

  1. Patients with a status of MRA "No"

  2. Patient in ICU at time of shock

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

  • Principal Investigator: Tonia M Mowbray-Donahue, MD, Allina Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT05073354
Other Study ID Numbers:
  • 50701
First Posted:
Oct 11, 2021
Last Update Posted:
May 16, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Shock

Study Results

No Results Posted as of May 16, 2022