The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams

NCT02186197 | Completed DMC

• 1 other identifier: 206-13
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Shock and respiratory failure are common reasons for admission to the intensive care unit (ICU) at our institution. The various causes of acute shock and respiratory failure are traditionally assessed with the use of history, physical examination, chest x-ray, EKG and laboratory studies. Unfortunately, much of this clinical information is either insensitive or non-specific. 1 Critical care ultrasound (CCUS) is a rapid and non-invasive tool, which has been shown to be useful in the intensive care unit to assist in the diagnosis and management of patients in shock or respiratory failure.2 The investigators hypothesize that the trained fellow's interpretation of critical care ultrasound images will be accurate when compared to experts and that ultrasounds will change diagnosis and management of the patient in shock and respiratory failure.

Conditions

Shock; Respiratory Failure

Keywords

Volume Responsiveness

Outcome Measures

Primary Outcomes (3)

• Diagnosis change

  The proportion of times that clinical diagnosis changes following performance of a bedside ultrasound.

  5 minutes

• Management changes

  The frequency and type of management changes that are made after performance of a critical care ultrasound.

  5 minutes

• Volume responsiveness agreement

  The proportion of time that post-ultrasound assessment of volume responsiveness agrees with the volume responsiveness conclusion made by a cheetah monitor immediately after ultrasound is performed.

  5 minutes

Secondary Outcomes (1)

• Ultrasound diagnosis agreement with final diagnosis

  72 hours following admission to the ICU

Study Arms (1)

Shock and/or Respiratory Failure

Other: Critical Care Ultrasound

Interventions

Critical Care Ultrasound OTHER

A critical care ultrasound exam will be performed on all patients included in this study

Shock and/or Respiratory Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to our intensive care unit with shock and/or respiratory failure

You may qualify if:

• Newly admitted to the medical ICU.
• Clinical diagnosis of shock including systolic blood pressure less than 90 mmhg, patients requiring vasopressors or indication of organ hypoperfusion.
• Clinical diagnosis of respiratory failure including need for invasive or non-invasive mechanical ventilation, needing supplemental oxygen more than 50% face mask, clinical impression of respiratory failure with respiratory rate greater than 25.

You may not qualify if:

• Patients not in shock or respiratory failure based on the above criteria.
• Patients in shock but with obvious cause of bleeding.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Mount Sinai Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Shock; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Pierre Kory, MD

  Mount Sinai Beth Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: July 10, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

US (1)