The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams

NCT03214809 | Terminated DMC

• 1 other identifier: NL61884.091.17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET)

Conditions

Dyspnea; Coma; Hypotension and Shock

Keywords

ultrasound; MET team; Concordance

Outcome Measures

Primary Outcomes (1)

• Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied

  final diagnosis will be determined by 2 independent experts on the basis of chart review and will be compared with the MET team diagnosis. There are 8 pre defined diagnosis categories. The difference in concordance between the MET diagnosis with and without the use of ultrasound with the definitive diagnosis will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  after 2-3 weeks

Secondary Outcomes (8)

• Possible difference in diagnostic certainty

  direct after inclusion

• Possible differences in initial treatment

  direct after inclusion

• Possible differences in patients' disposition

  direct after inclusion

• Whether the use of ultrasound was considered to be helpful

  direct after inclusion

• MET physicians characteristics

  direct after inclusion

Study Arms (2)

Thoracic ultrasound protocol

EXPERIMENTAL

ABCDE algorithm with Thoracic ultrasound protocol

Diagnostic Test: ultrasound protocol

No Thoracic ultrasound protocol

NO INTERVENTION

ABCDE algorithm without Thoracic ultrasound protocol

Interventions

ultrasound protocol DIAGNOSTIC_TEST

after first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor

Thoracic ultrasound protocol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients on the general wards in need of treatment by the MET team.

You may not qualify if:

• age (\<18 years),
• pregnancy:

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

Related Publications (1)

• Blans MJ, Bousie E, van der Hoeven JG, Bosch FH. A point-of-care thoracic ultrasound protocol for hospital medical emergency teams (METUS) improves diagnostic accuracy. Ultrasound J. 2021 Jun 4;13(1):29. doi: 10.1186/s13089-021-00229-3.

  PMID: 34089087 DERIVED

MeSH Terms

Conditions

Dyspnea; Coma; Hypotension; Shock

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Michael Blans, MD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 12, 2017
• Study Start: January 18, 2019
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)