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

Not Applicable

Terminated

• Conditions: Hypotension and Shock; Dyspnea; Coma
• Interventions: Diagnostic Test: ultrasound protocol

• Registration Number: NCT03214809
• Lead Sponsor: Rijnstate Hospital

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)

Detailed Description

Rationale: Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams Objective: Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.

Study design prospective, interventional study Study population: patients on the general wards in need treatment by the MET team Intervention (if applicable): 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.

Main study parameters/endpoints:

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

Also other secondary endpoints will be evaluated.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The use of ultrasound is without direct side effects in terms of radiation or other potential (non)physical disturbances.

There are no data on the effects of the use of ultrasound during MET calls. The MET team will first deliver acute care if necessary, the ultrasound protocol can be done within 10-15 minutes which is acceptable in terms of MET call care. The MET team physician can at any point decide to use the ultrasound if he/she thinks it is necessary.

In other circumstances (e.g. emergency department or intensive care units) point-of-care ultrasound is considered to be part of standard care.

The investigators will study the potential influence of ultrasound during MET calls in terms of accuracy of the initial diagnosis and whether ultrasound influences initial treatment, patients' disposition and so on, ultrasound is no treatment nor will be the use of ultrasound be decisive in the treatment of MET call patients in this study.

Study Timeline

• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-12
• Study Start: 2019-01-18
• Primary Completion: 2020-05-11
• Study Completion: 2020-05-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• age (<18 years),
• pregnancy:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic ultrasound protocol	ultrasound protocol	ABCDE algorithm with Thoracic ultrasound protocol

Primary Outcome Measures

Name	Time	Method
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied	after 2-3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Possible difference in the need for supervisor attendance	direct after inclusion	the answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Number of times ultrasound was used in te "non-ultrasound weeks"	direct after inclusion	answer to this question is a number. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test
Possible difference in the time needed to reach a diagnosis	direct after inclusion	time in minutes. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.
Possible differences in patients' disposition	direct after inclusion	There are 4 pre-defined categories in patients' disposition. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Possible difference in diagnostic certainty	direct after inclusion	diagnostic certainty is measured on a scale 0-10. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.
Possible differences in initial treatment	direct after inclusion	There are 11 pre-defined therapy categories. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Whether the use of ultrasound was considered to be helpful	direct after inclusion	The answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
MET physicians characteristics	direct after inclusion	there are 5 pre-defined categories in MET physician characteristics. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands