## Protocol Section
### Identification Module
**NCT ID:** NCT04882579

**Brief Title:** Point-of-care Ultrasound in Suspected Pulmonary Embolism

**Official Title:** Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial

#### Organization Study ID Info
**ID:** PulmonaryEmbolismPoCUSOdense
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2023-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-03

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-06-15

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-05-12
**Type:** ACTUAL
**Study First Submit Date:** 2021-04-12
**Study First Submit QC Date:** 2021-05-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Southern Denmark

**Class:** OTHER

**Name:** Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

**Class:** OTHER

**Name:** Odense Patient Data Explorative Network

#### Lead Sponsor

**Class:** OTHER

**Name:** Odense University Hospital

#### Responsible Party

**Investigator Affiliation:** Odense University Hospital

**Investigator Full Name:** Casper Falster

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Pulmonary embolism (PE) is a common cardiovascular condition with an estimated incidence of 0.60 to 1.12 per 1000 inhabitants in the United States of America, and the diagnosis is challenging as patients with PE present with a wide array of symptoms.

Computed tomography pulmonary angriography (CTPA) and lung ventilation-perfusion scintigraphy (VQ) are considered the gold-standards in PE-diagnostics but may not always be feasible. CTPA is contraindicated by contrast allergy or renal failure and both modalities require involvement of multiple staff-members and transport of the patient. Lung scintigraphy cannot be performed in an emergency situation, with unstable patients and patients unable to comply to the examination.

Ultrasound represent a possible tool in confirming or dismissing clinical PE suspicion. Ultrasound is non-invasive and can be performed bedside by the clinician, an approach known as point-of-care ultrasound (PoCUS), reducing both time, radiation-exposure and costs.

The aim of this study is to investigate whether integrating cardiac, lung and deep venous ultrasound in the clinical evaluation of suspected PE reduces the need for referral to CTPA or lung scintigraphy, during emergency department work up, while maintaining safety standards.

**Detailed Description:** All ultrasound examinations will be performed by a physician certified in ultrasound by the Danish Society for Emergency Physicians in accordance with the Danish Health Agency.

Based on ultrasonographic findings, PE suspicion is allocated to one of three categories:

1. Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:

1. Visible proximal deep venous thrombus
2. ≥2 hypoechoic subpleural lung consolidations with a diameter of ≥0,5cm
3. Visible right ventricular thrombus
4. McConnell's sign if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
5. D-sign present in both systole and diastole if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease

If PE is confirmed by ultrasound, the physician will apply the simplified pulmonary embolism severity index score (sPESI) and estimate risk of mortality within 30 days based on clinical signs and symptoms, cardiac troponin level and RV dysfunction. Patients with intermediate-high or high risk, requiring admission to a cardiology department will be referred for CTPA. Patients with low or intermediate-low risk, not requiring admission, will be discharged with anticoagulative treatment.

A thorough presentation of the sPESI-score and early mortality risk assessment is available in the 2019 collaborative guidelines by the ERS and ESC on the diagnosis and management of PE.

2. Further diagnostic imaging (CTPA or V/Q) required if ≥1 of the following ultrasound findings:

1. 1 hypoechoic subpleural lung consolidation with a diameter of ≥0,5cm
2. Pleural effusion not explained by other cause
3. Basal RVEDD/LVEDD \>1.0 or an RV visibly larger than the LV
4. TAPSE \<17 mm
5. No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus but strong clinical suspicion.
6. McConnell's or D-sign in the presence of known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease

If PE suspicion can be neither dismissed nor confirmed after ultrasound investigation, the patient will be referred to further investigation as usual with CTPA or lung scintigraphy. Subsequent plan will be in accordance with department guidelines.

3. Clinical suspicion of PE dismissed if ≥1 of the following ultrasound findings:

1. No deep venous thrombus, no lung consolidation or effusion, no signs of RV strain or thrombus and a plausible differential diagnosis or low clinical suspicion
2. Obvious differential diagnosis demonstrated on ultrasound (i.e., pneumonia, pneumothorax, interstitial syndrome, left sided heart failure)

If PE suspicion is dismissed by ultrasound investigation, the patient will be either discharged or subject to further investigations in accordance with department guidelines if indicated.

### Conditions Module

**Conditions:**

- Pulmonary Embolism

- Pulmonary Embolus/Emboli

**Keywords:**

- Ultrasound

- Diagnosis

- Ultrasonography

- Echocardiography

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 150 patients with suspected pulmonary embolism, requiring CTPA or VQ to finally confirm or dismiss the diagnosis will be enrolled and randomized 1:1 to receive a multiorgan ultrasound investigation or continue to CTPA or VQ as planned.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 150

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients allocated to the PoCUS investigation arm will receive an ultrasound investigation resulting in either confirmation or dismissal of pulmonary embolism suspicion or requiring CTPA or VQ

**Intervention Names:**

- Diagnostic Test: Point-of-care-ultrasound examination

**Label:** PoCUS group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients allocated to the control group will continue with CTPA or VQ without PoCUS investigation

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PoCUS group

**Description:** The intervention consists of three ultrasound modalities:

1. Cardiac ultrasound assessing signs of right ventricular strain or other obvious pathology.
2. Deep venous ultrasound assessing presence of a deep venous thrombus
3. Lung ultrasound assessing presence of pulmonary infarctions, pleural effusion, pneumothorax or interstitial syndrome.

**Name:** Point-of-care-ultrasound examination

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of patients referred to CTPA or VQ after multiorgan PoCUS

**Time Frame:** Up to 24 hours

#### Secondary Outcomes

**Measure:** Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death

**Time Frame:** 3 months

**Measure:** Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.

**Time Frame:** Up to 24 hours

**Measure:** Proportion of included patients diagnosed with PE in the control and intervention group

**Time Frame:** Up to 24 hours

**Measure:** Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group

**Time Frame:** Up to 24 hours

**Measure:** Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation

**Time Frame:** Up to 24 hours

**Measure:** Proportion of patients in the reference and control group admitted to a cardiology department for telemetry monitoring (i.e. high risk PE) following clinical evaluation.

**Time Frame:** Up to 24 hours

**Measure:** Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation

**Time Frame:** Up to 24 hours

**Measure:** Proportion of patients in the reference and control group referred to supplementary CTPA or lung scintigraphy within 30 days after inclusion

**Time Frame:** 30 days

**Measure:** Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2

**Time Frame:** Up to 1 year

**Measure:** Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Referred or Admitted to an emergency department
* Clinical suspicion of PE raised by physician requiring further diagnostic imaging (Well's score 0-6 with elevated age-adjusted D-dimer or Wells score \>6 regardless of D-dimer)

Exclusion Criteria:

* Refusal of informed consent
* Pregnancy
* Permanent mental disability
* Age \<18 years
* Diagnosis of PE within the last 6 months
* Hemodynamic instability (systolic blood pressure \<90 mmHg for at least two consecutive measurements)
* Ultrasound of heart, lungs or deep veins performed prior to enrollment

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Esbjerg

**Country:** Denmark

**Facility:** Esbjerg Hospital

**Zip:** 6700

**Location 2:**

**City:** Kolding

**Country:** Denmark

**Facility:** Kolding Hospital

**Zip:** 6000

**Location 3:**

**City:** Odense

**Country:** Denmark

**Facility:** Odense University Hospital

**Zip:** 5000

**Location 4:**

**City:** Slagelse

**Country:** Denmark

**Facility:** Slagelse hospital

**Zip:** 4200

**Location 5:**

**City:** Svendborg

**Country:** Denmark

**Facility:** Svendborg Hospital

**Zip:** 5700

#### Overall Officials

**Official 1:**

**Affiliation:** Odense University Hospital

**Name:** Casper Falster, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Odense University Hospital

**Name:** Christian B Laursen, Prof. MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14509

- Name: Pulmonary Embolism

- Relevance: HIGH

- As Found: Pulmonary Embolism

- ID: M7784

- Name: Embolism

- Relevance: HIGH

- As Found: Embolism

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011655

- Term: Pulmonary Embolism

- ID: D000004617

- Term: Embolism

### Misc Info Module

- Version Holder: 2024-05-24
