Sonography in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms

Chest Pain Clinical Trial

Official title:

Focused Sonographic Examination of the Heart, Lungs and Deep Veins in an Unselected Population of Acute Admitted Patients With Respiratory Symptoms: a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486394
• Other study ID #: S-2010074
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: August 2, 2013
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether focused sonography of the heart, lungs and deep veins can increase the number of patients with respiratory symptoms correctly diagnosed in an emergency department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

All 4 of the following must be present:

1. The sonographic examination can be performed before or within 1 hour after the primary evaluation

2. Patient is 18 years or older

3. Patient able and willing to give informed consent

4. One ore more of the following symptoms or clinical findings at admission to the emergency department

• Respiratory rate > 20 breaths per minute

• Saturation < 95%

• Oxygen therapy initiated

• The patient has a principal complaint of dyspnoea

• The patient has a principal complaint of coughing

• The patient has a principal complaint of chest pain

Exclusion Criteria:

One of the following:

1. The sonographic examination can not be performed within 1 hour after the primary evaluation

2. The patient is 17 years or younger

3. The patient not able or willing to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain
• Cough
• Dyspnoea
• Signs and Symptoms, Respiratory

Intervention

Other:
• Focused Sonography of the heart, lungs and deep veins
The patient is randomised to either a control group where usual treatment and diagnostic work-up is performed or to an intervention group where usual treatment and diagnostic workup are supplemented by a sonographic examination of the heart, lungs and deep veins are performed within one hour after the primary evaluation. The primary evaluation is defined as the first evaluation of the patient by a physician in the Acute Medical Admission Department.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.	The 4-hour presumptive diagnosis are compared to the final diagnosis obtained by audit after the patient has been discharged from the hospital (gold standard).	4 hours after hospital admission	No
Secondary	Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	30 day mortality		30 days after the patient has been admitted to the hospital	No
Secondary	In-hospital mortality		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Number of patients transferred to an intensive care unit		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Number of patients given an appropriate, inappropriate and no specific treatment after primary evaluation in the control group and after sonography in the intervention group		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Time to diagnostic / therapeutic thoracocentesis		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No
Secondary	Length of hospital stay		Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks	No