Ultrasound-guidance for Intraosseous Access During Earthquake
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ClinicalTrials.gov Identifier: NCT03491787 |
Recruitment Status :
Completed
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
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Sponsor:
San Salvatore Hospital of L'Aquila
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila
Tracking Information | |||||||
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First Submitted Date | March 28, 2018 | ||||||
First Posted Date | April 9, 2018 | ||||||
Last Update Posted Date | April 9, 2018 | ||||||
Actual Study Start Date | September 26, 2016 | ||||||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Intraosseus access [ Time Frame: up to 10 minutes ] The time used to esteblish the intraosseus access
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
Return of spontaneous circulation [ Time Frame: up to 1 hour ] The time to obtain the return of spontaneous circulation
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Ultrasound-guidance for Intraosseous Access During Earthquake | ||||||
Official Title | Ultrasound-guidance for Intraosseous Access Could Provide Benefits for Resuscitation in Out-of-hospital Traumatic Cardiac Arrest: a Field Report During Earthquake on Amatrice (Italy), August 24, 2016 | ||||||
Brief Summary | The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest | ||||||
Detailed Description | The aim of this field report is to describe as the use ultrasound guidance can facilitate the insertion of intraosseous access, decreasing the time for drug administration and providing some benefits during the resuscitation, in the victims of out-of hospital traumatic cardiac arrest. | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | People under the rubble, after the earthquake | ||||||
Condition | Cardiac Arrest Due to Trauma (Disorder) | ||||||
Intervention | Device: Ultrasound guidance
The ultrasound guidance was used to obtain intraosseous access
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
31 | ||||||
Original Actual Enrollment | Same as current | ||||||
Actual Study Completion Date | December 2016 | ||||||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03491787 | ||||||
Other Study ID Numbers | 05/01/2017, n.12 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Emiliano Petrucci, San Salvatore Hospital of L'Aquila | ||||||
Study Sponsor | San Salvatore Hospital of L'Aquila | ||||||
Collaborators | Not Provided | ||||||
Investigators | Not Provided | ||||||
PRS Account | San Salvatore Hospital of L'Aquila | ||||||
Verification Date | April 2018 |