ShockNCT02186197
The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams
An observational study of Shock and Respiratory Failure, run by Beth Israel Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Respiratory Failure
- What is being tested?
- Critical Care Ultrasound
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to our intensive care unit with shock and/or respiratory failure
Who may be able to join
- 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.
Who cannot join
- Patients not in shock or respiratory failure based on the above criteria.
- Patients in shock but with obvious cause of bleeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Beth Israel Medical Center
New York, New York, 10003
About this study
Official title: The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams on the Diagnosis and Management of Shock and Respiratory Failure
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.
Read the detailed description
In recent years, CCUS has become widely used by clinicians in the field of critical care as a rapid and non-invasive tool for providing diagnostic information. At Beth Israel Medical Center, CCUS has been routinely used for over a decade on a daily basis by both fellows and attending to aid in the diagnosis and management of shock and respiratory failure.
Numerous studies have described the accuracy and speed of clinician-performed critical care ultrasound. Recently it was shown that early critical care ultrasound by attendings can modify admitting diagnosis and in many cases change management. This study was done by expert practitioners and not by trainees. The accuracy of fellow image interpretation or the proportion of time that a fellow-performed ultrasound exam changes diagnosis or management has not been studied.
The protocol used in this study has already been implemented as part of the diagnostic assessment of a critically ill patients in our care and as an educational tool to help fellows learn ultrasound. The goal of this study is organize the existing clinical data to determine the accuracy of fellow interpretation along with the diagnostic impact of fellow performed CCUS.
Methods:
This is an observational study to see how accurately subjects (fellows) perform CCUS and what impact CCUS has on the early diagnosis of shock and respiratory failure in our ICU. This study involves collection and analysis of ultrasound exam results that are already being performed and documented as standard practice in our institution.
All pulmonary and critical care fellows who have attended the GNYHA ultrasound course during fellowship will be eligible for this study. Fellows also will attend pre-existing monthly lectures to discuss CCUS techniques and cases.
If a patient is to be evaluated in our study they should be newly admitted from the ER and the ultrasound assessment performed within 30 minutes of arrival to the medical intensive care unit. A fellow will document their initial indication for ultrasound on a standard assessment form followed by documentation of how much fluids the patient has received since admission. Based on the results of physical exam and ancillary testing the fellow will document pre-ultrasound diagnosis of shock and respiratory failure along with their initial assessment of whether the patient would respond to fluid bolus administration along with how much fluids the patient has gotten since arriving from the emergency room. This initial assessment will also be documented in the qpath database via the ultrasound machine. They will then document if they believe any diagnostic tests are indicated and the reason for ordering as well as any therapeutics indicated. They will then document their assessment of the diagnostic impact of the ultrasound exam to be performed.
A CCUS will then be performed on patients in shock or respiratory failure as is already protocol in our ICU. The ultrasound exam will be performed within 1 hour of arrival to the ICU. All images obtained will be saved to a password protected cloud database as is already our protocol. The ultrasound will require approximately 10 minutes and will not in hold up other tests or therapeutic interventions. The fellow will document the quality of images obtained and then pertinent findings on cardiac, lung, renal, vascular and abdominal exam.
Following performance of CCUS, the fellow will document post-ultrasound cause of shock, respiratory failure and volume responsiveness along with any other findings. They will then document if any diagnostic or therapeutic management changes are planned that differ from their pre ultrasound assessment and the reasons for the change in diagnostic or therapeutic plan.
An assessment of volume responsiveness using a CHEETAH non-invasive cardiac output hemodynamic monitor will then be performed directly after the ultrasound. This device is non-invasive and is already being used with frequency in the MICU, SICU and CCU of our institution to provide non-invasive assessment of whether a patient will respond to fluid challenge. The result of the test for volume responsiveness will be recorded on the standard assessment form.
All ultrasound exams will be submitted via the database for review by an attending expert clinician as is already standard practice in our training program. 72 hours following admission the ICU attending physician will be asked to document the final diagnosis and cause of shock or respiratory failure. The final diagnosis will be compared with the post-ultrasound diagnosis to measure the degree of variation.
The Phillips Sparq ultrasound is the machine most commonly used in our MICU. It has the ability to save images to a password protected cloud database and will thus be used in this study.
The study investigators will obtain all SAF's as well as the 'final' diagnosis from the attending physician at 72hours, and will enter this data into a database that will not contain any unique patient identifiers.
A waiver of informed consent will be requested in order to use the patients protected health information. This is appropriate since the research data will be de-identified and will not impact the patient's medical care.
- Conditions
- Shock, Respiratory Failure
- Being tested
- Critical Care Ultrasound
- Keywords
- Volume Responsiveness
- Medical subject headings
- Shock, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Care UltrasoundOther
A critical care ultrasound exam will be performed on all patients included in this study
| Study group | Role | What they receive |
|---|---|---|
| Shock and/or Respiratory Failure | Not described Receives: Other: Critical Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis change
The proportion of times that clinical diagnosis changes following performance of a bedside ultrasound.
Measured: 5 minutes
Management changes
The frequency and type of management changes that are made after performance of a critical care ultrasound.
Measured: 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.
Measured: 5 minutes
Secondary outcomes (1)
Ultrasound diagnosis agreement with final diagnosis
The proportion of the time that ultrasound diagnosis regarding etiology of shock and/or respiratory failure agrees with diagnosis 72 hours later in comparison to the pre-ultrasound clinical diagnosis
Measured: 72 hours following admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Kory, MD, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186197
- Sponsor's protocol ID
- 206-13
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2014
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fellow-performed Cardiopulmonary Ultrasound Exams on the Diagnosis and Management of Shock and Respiratory Failure
- ClinicalTrials.gov ID
- NCT02186197
- Acronym / sponsor ID
- 206-13
- Conditions
- Shock, Respiratory Failure
- Keywords
- Volume Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent years, CCUS has become widely used by clinicians in the field of critical care as a rapid and non-invasive tool for providing diagnostic information. At Beth Israel Medical Center, CCUS has been routinely used for over a decade on a daily basis by both fellows and attending to aid in the diagnosis and management of shock and respiratory failure.
Numerous studies have described the accuracy and speed of clinician-performed critical care ultrasound. Recently it was shown that early critical care ultrasound by attendings can modify admitting diagnosis and in many cases change management. This study was done by expert practitioners and not by trainees. The accuracy of fellow image interpretation or the proportion of time that a fellow-performed ultrasound exam changes diagnosis or management has not been studied.
The protocol used in this study has already been implemented as part of the diagnostic assessment of a critically ill patients in our care and as an educational tool to help fellows learn ultrasound. The goal of this study is organize the existing clinical data to determine the accuracy of fellow interpretation along with the diagnostic impact of fellow performed CCUS.
Methods:
This is an observational study to see how accurately subjects (fellows) perform CCUS and what impact CCUS has on the early diagnosis of shock and respiratory failure in our ICU. This study involves collection and analysis of ultrasound exam results that are already being performed and documented as standard practice in our institution.
All pulmonary and critical care fellows who have attended the GNYHA ultrasound course during fellowship will be eligible for this study. Fellows also will attend pre-existing monthly lectures to discuss CCUS techniques and cases.
If a patient is to be evaluated in our study they should be newly admitted from the ER and the ultrasound assessment performed within 30 minutes of arrival to the medical intensive care unit. A fellow will document their initial indication for ultrasound on a standard assessment form followed by documentation of how much fluids the patient has received since admission. Based on the results of physical exam and ancillary testing the fellow will document pre-ultrasound diagnosis of shock and respiratory failure along with their initial assessment of whether the patient would respond to fluid bolus administration along with how much fluids the patient has gotten since arriving from the emergency room. This initial assessment will also be documented in the qpath database via the ultrasound machine. They will then document if they believe any diagnostic tests are indicated and the reason for ordering as well as any therapeutics indicated. They will then document their assessment of the diagnostic impact of the ultrasound exam to be performed.
A CCUS will then be performed on patients in shock or respiratory failure as is already protocol in our ICU. The ultrasound exam will be performed within 1 hour of arrival to the ICU. All images obtained will be saved to a password protected cloud database as is already our protocol. The ultrasound will require approximately 10 minutes and will not in hold up other tests or therapeutic interventions. The fellow will document the quality of images obtained and then pertinent findings on cardiac, lung, renal, vascular and abdominal exam.
Following performance of CCUS, the fellow will document post-ultrasound cause of shock, respiratory failure and volume responsiveness along with any other findings. They will then document if any diagnostic or therapeutic management changes are planned that differ from their pre ultrasound assessment and the reasons for the change in diagnostic or therapeutic plan.
An assessment of volume responsiveness using a CHEETAH non-invasive cardiac output hemodynamic monitor will then be performed directly after the ultrasound. This device is non-invasive and is already being used with frequency in the MICU, SICU and CCU of our institution to provide non-invasive assessment of whether a patient will respond to fluid challenge. The result of the test for volume responsiveness will be recorded on the standard assessment form.
All ultrasound exams will be submitted via the database for review by an attending expert clinician as is already standard practice in our training program. 72 hours following admission the ICU attending physician will be asked to document the final diagnosis and cause of shock or respiratory failure. The final diagnosis will be compared with the post-ultrasound diagnosis to measure the degree of variation.
The Phillips Sparq ultrasound is the machine most commonly used in our MICU. It has the ability to save images to a password protected cloud database and will thus be used in this study.
The study investigators will obtain all SAF's as well as the 'final' diagnosis from the attending physician at 72hours, and will enter this data into a database that will not contain any unique patient identifiers.
A waiver of informed consent will be requested in order to use the patients protected health information. This is appropriate since the research data will be de-identified and will not impact the patient's medical care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock and/or Respiratory Failure | – | Other: Critical Care Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to our intensive care unit with shock and/or respiratory failure
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients not in shock or respiratory failure based on the above criteria.
- Patients in shock but with obvious cause of bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical Care UltrasoundA critical care ultrasound exam will be performed on all patients included in this study | Other | Shock and/or Respiratory Failure |
Primary outcome
Diagnosis change
Time frame: 5 minutes
The proportion of times that clinical diagnosis changes following performance of a bedside ultrasound.
Management changes
Time frame: 5 minutes
The frequency and type of management changes that are made after performance of a critical care ultrasound.
Volume responsiveness agreement
Time frame: 5 minutes
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.
1 secondary outcome
Ultrasound diagnosis agreement with final diagnosis
Time frame: 72 hours following admission to the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Kory, MD principal investigator
Mount Sinai Beth Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Respiratory Failure, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis change (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.