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Completed

NCT Number: NCT01486394

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

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.

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Key information

Conditions

Dyspnoea Chest Pain Cough Dyspnea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Fyn, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All 4 of the following must be present:

  • The sonographic examination can be performed before or within 1 hour after the primary evaluation
  • Patient is 18 years or older
  • Patient able and willing to give informed consent
  • 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:

  • The sonographic examination can not be performed within 1 hour after the primary evaluation
  • The patient is 17 years or younger
  • The patient not able or willing to give informed consent

Treatment and study plan

Focused Sonography of the heart, lungs and deep veins

Other

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.

Primary outcomes

  1. The number of patients with a correct presumptive diagnosis within 4 hours after hospital admission.

    Time frame: 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).

Secondary outcomes

  1. Number of patients with a correct presumptive diagnosis after primary evaluation in the control group and after sonography in the intervention group.

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  2. Sensitivity, specificity, positive predictive values, negative predictive values and diagnostic accuracy of the primary evaluation and the "4-hour" presumptive diagnosis.

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  3. Number of patients receiving appropriate, inappropriate and no specific treatment 4-hours after admission

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  4. 30 day mortality

    Time frame: 30 days after the patient has been admitted to the hospital

  5. In-hospital mortality

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  6. Number of patients transferred to an intensive care unit

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  7. 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

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  8. Time to diagnostic / therapeutic thoracocentesis

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

  9. Length of hospital stay

    Time frame: Participants will be followed for the duration of the hospital stay, an expected range of up to 5 weeks

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2011
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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