Sonography in Hypotension and Cardiac Arrest in the Emergency Department. (SHoC-ED 1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01419106|
Recruitment Status : Unknown
Verified June 2015 by Paul Atkinson, Horizon Health Network.
Recruitment status was: Recruiting
First Posted : August 17, 2011
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypotension Point of Care Ultrasound Shock||Device: Ultrasound (A point of care ultrasound protocol)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SHoC-ED 1: Sonography in Hypotension and Cardiac Arrest in the Emergency Department.|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||July 2016|
No Intervention: Control
This arm of the study will NOT receive point of care ultrasound. They will receive all other standard care implemented during their visit to the ED (currently, ultrasound is NOT standard of care). The same blood tests will be done in both groups, as this will offer a means of comparing physiological changes between the two arms.
This group WILL receive point of care ultrasound. The protocol they will receive is the ACES protocol (described above).
Device: Ultrasound (A point of care ultrasound protocol)
Bedside ultrasound will be used to view any intraperitoneal bleeding, pleural fluid, cardiac abnormalities, or structural abnormalities of major blood vessels. The results of this test will then be used to determine the best course of treatment for the patient.
- Patient Mortality Rates (7-day, 30 Day or Hospital Discharge) [ Time Frame: 7-day, 30 Day or Hospital Discharge ]Determine the proportion of patients living at 7-day, 30 Day or Hospital Discharge
- Time taken to appropriate intervention [ Time Frame: Within 8 hours ]This is a measure that will be done to determine how long after initial diagnosis "appropriate" interventions are taken. This will be done by reviewing the patient's chart, identifying what the ultimate diagnosis for the patient was (resultant of testing that occurs as patient progresses through system), and seeing when propoer intervention was taken.
- Unexpected change in diagnosis [ Time Frame: First hour ]If ED physician's expectations prior to performing ultrasound is AAA, but post ultrasound diagnosis is septic shock, this would be an example of an unexpected change in diagnosis. This measure will only be performed in the ultrasound group, as the purpose is to identify how often performing ultrasound will result in diagnosis changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419106
|Contact: Paul Atkinson, MD||1 506 343-0850||Paul.Atkinson@Dal.ca|
|Contact: James D Milne, MD (Student)||1 506 firstname.lastname@example.org|
|University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada|
|Contact: Chau Pham, MD email@example.com|
|Principal Investigator: Chau Pham, MD|
|Canada, New Brunswick|
|Saint John Regional Hospital||Recruiting|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Contact: Paul Atkinson, MD firstname.lastname@example.org|
|Contact: Jacky Fraser, BN email@example.com|
|Principal Investigator: Paul Atkinson, MD|
|Saskatoon Health Region||Active, not recruiting|
|Saskatoon, Saskatchewan, Canada, S7K 0M7|
|GF Jooste Hospital||Active, not recruiting|
|Manenberg, Cape Town, South Africa, 7764|
|Tygerberg Hospital||Active, not recruiting|
|Cape Town, Western Cape, South Africa|
|Khayelitsha Hospital||Active, not recruiting|
|Cape Town, South Africa|
|Principal Investigator:||James D Milne, MD (Student)||Dalhousie Medical School|
|Principal Investigator:||Paul Atkinson, MD||Saint John Regional Hospital, Horizon Health Network|
|Study Director:||Jacqueline Fraser, BN||Saint John Regional Hospital, Horizon Health Network|