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Ultrasound-guidance for Intraosseous Access During Earthquake

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: NCT03491787
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Tracking Information
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
 (submitted: April 6, 2018)		 Intraosseus access [ Time Frame: up to 10 minutes ]
The time used to esteblish the intraosseus access
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 6, 2018)		 Return of spontaneous circulation [ Time Frame: up to 1 hour ]
The time to obtain the return of spontaneous circulation
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
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
Study Groups/Cohorts
  • Ultrasound guidance
    The ultrasound guidance was used to establish intraosseous access
    Intervention: Device: Ultrasound guidance
  • Not ultrasound guidance
    The ultrasound guidance was not used to obtain intraosseous access
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 6, 2018)		 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:

  • traumatic cardiac arrest

Exclusion Criteria:

  • non traumatic cardiac arrest
  • beheading
  • post-mortem hypostasis
  • carbonized bodies
  • dismembered bodies
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
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