Rapid Treatment of Shock Without Trauma

Completed

• Conditions: Shock
• Interventions: Device: Full SWOT Model

• Registration Number: NCT05073354
• Lead Sponsor: Zoll Medical Corporation

Brief Summary

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

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 Timeline

• Study Start: 2021-06-29
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full-implementation	Full SWOT Model	Patients experiencing shock without trauma once all training is in place and devices are deployed

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States