ShockSWOTNCT05073354
Rapid Treatment of Shock Without Trauma
An observational study of Shock, run by Zoll Medical Corporation at 1 site in United States.
Trial summary
Evaluate the implementation of a standardized mobile resuscitation model to manage SWOT within a large acute care hospital setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shock
- What is being tested?
- Full SWOT Model
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients meeting all enrollment criteria will be eligible for enrollment in the study.
Who may be able to join
- 18 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
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- 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
- Rapid Response Team call or request
- 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:
- Interventional assessment and treatment by SWOT Team (full-implementation period only)
- 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")
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Implementation of a Mobile In-hospital Resuscitation Model for the Rapid Treatment of Shock Without Trauma (SWOT)
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%
- Conditions
- Shock
- Being tested
- Full SWOT Model
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full SWOT ModelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Full-implementation | Patients experiencing shock without trauma once all training is in place and devices are deployed Receives: Device: Full SWOT Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days after initial shock event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start29 Jun 2021
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tonia M Mowbray-Donahue, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073354
- Sponsor's protocol ID
- 50701
- Acronym
- SWOT
- Status last verified
- Jul 2024
- First submitted
- 28 Sep 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Mobile In-hospital Resuscitation Model for the Rapid Treatment of Shock Without Trauma (SWOT)
- ClinicalTrials.gov ID
- NCT05073354
- Acronym / sponsor ID
- SWOT / 50701
- Conditions
- Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-implementation | – | Device: Full SWOT ModelPatients experiencing shock without trauma once all training is in place and devices are deployed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting all enrollment criteria will be eligible for enrollment in the study.
Key inclusion criteria (20 listed)
- 18 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):
- Admitted to Abbott Northwestern
- Rapid Response Team call or request
- 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")
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full SWOT ModelBundle 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. | Device | Full-implementation |
Primary outcome
Time to Shock Reversal
Time frame: 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
1 secondary outcome
30-day Mortality
Time frame: 30 days after initial shock event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Shock
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Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonia M Mowbray-Donahue, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Zoll Medical Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Shock Reversal (time frame: From 24 hours to 72 hours after initial shock event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.