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CompletedNCT05073354SWOTUpdated Jul 24, 2024

Rapid Treatment of Shock Without Trauma

An observational study in Shock, sponsored by Zoll Medical Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Zoll Medical Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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%
02

Conditions studied

  • Shock

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03

In context

Shock

921 studies on the registry are indexed under Shock; 172 are open to participants now.

This study's enrollment of 27 is below the median of 93 across 355 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Zoll Medical Corporation is the lead sponsor of 35 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  3. Admitted to Abbott Northwestern
  4. Rapid Response Team call or request
  5. 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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Full-implementation

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

    Device: Full SWOT Model

Interventions

  • DeviceFull 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.

06

What researchers measure

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

    Time frame: From 24 hours to 72 hours after initial shock event

Secondary outcomes

  1. 30-day Mortality

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

    Time frame: 30 days after initial shock event

07

Study locations

1 site
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05073354
Responsible party
Sponsor
First posted
Oct 11, 2021
Start date
Jun 29, 2021
Primary completion
Apr 5, 2024
Completion
Apr 5, 2024
Last update
Jul 24, 2024

Study contacts

Tonia M Mowbray-Donahue, MD
principal investigator · Allina Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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