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出境医 / 临床实验 / Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)

Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)

Study Description
Brief Summary:

Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.

Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation stepped wedge design in both Lee County EMS and Nassau County Fire Rescue Department, we will enroll between 300-500 patients over a three-year period o analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.


Condition or disease Intervention/treatment Phase
Asthma in Children Drug: Prednisolone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a stepped wedge design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Early Prehospital Systemic Corticosteroids
Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
 Drug: Prednisolone
During a sequenced rollout protocol change for Lee County EMS, certain ambulance stations who are randomized to early adoption of an upcoming protocol change will administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. Ambulance randomized to later protocol adoption will continue usual care, until the end of the study when all ambulance stations adopt the new protocol with early administration of prednisolone
No Intervention: Usual Care
Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids
Outcome Measures
Primary Outcome Measures :
  1. Hospital Admission [ Time Frame: Day 1 (ED stay) ]
    Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation


Secondary Outcome Measures :
  1. Emergency Department length-of-stay [ Time Frame: Day 1 (from EMS arrival to ED discharge) ]
    Length of time in emergency department for patients who are discharged home


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary problem: Asthma exacerbation
  • stable to take an oral medication
  • transported by EMS to an ED

Exclusion Criteria:

  • unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
  • daily or every other day corticosteroid therapy
  • allergy to prednisolone or another corticosteroid
  • chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Contacts and Locations

Contacts
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Contact: Jennifer Fishe, MD 904-244-5812 Jennifer.fishe@jax.ufl.edu
Contact: Michelle Lott Michelle.Lott@jax.ufl.edu

Locations
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United States, Florida
Walton County EMS Recruiting
DeFuniak Springs, Florida, United States, 32433
Contact: Tim Turner    850-892-8111    turtim@waltonso.org   
Lee County Public Safety & Emergency Services Recruiting
Fort Myers, Florida, United States, 33905
Contact: Benjamin Abes    239-533-3911    Benjamin.Abes@leegov.com   
Contact: Jennifer Fishe, MD    804-931-7567    Jennifer.Fishe@jax.ufl.edu   
Sarasota County EMS Recruiting
Sarasota, Florida, United States, 34236
Contact: Marshall Frank, MD    941-861-5000    fmarshall@scgov.net   
Leon County EMS Recruiting
Tallahassee, Florida, United States, 32301
Contact: Mac Kemp    850-606-2100    kempm@leoncountyfl.gov   
Contact: Kim Landry, MD    850-606-2100    landryk@leoncountyfl.gov   
Nassau County Fire Rescue Department Recruiting
Yulee, Florida, United States, 32097
Contact: Jennifer Fishe, MD    804-931-7567    Jennifer.Fishe@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Fishe, MD University of Florida
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Hospital Admission [ Time Frame: Day 1 (ED stay) ]
Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Emergency Department length-of-stay [ Time Frame: Day 1 (from EMS arrival to ED discharge) ]
Length of time in emergency department for patients who are discharged home
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Administration of Steroids in the Ambulance Setting
Official Title  ICMJE Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Brief Summary

Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival.

Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation stepped wedge design in both Lee County EMS and Nassau County Fire Rescue Department, we will enroll between 300-500 patients over a three-year period o analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a stepped wedge design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma in Children
Intervention  ICMJE Drug: Prednisolone
During a sequenced rollout protocol change for Lee County EMS, certain ambulance stations who are randomized to early adoption of an upcoming protocol change will administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. Ambulance randomized to later protocol adoption will continue usual care, until the end of the study when all ambulance stations adopt the new protocol with early administration of prednisolone
Study Arms  ICMJE
  • Experimental: Early Prehospital Systemic Corticosteroids
    Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
    Intervention: Drug: Prednisolone
  • No Intervention: Usual Care
    Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2020) 		650
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		140
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary problem: Asthma exacerbation
  • stable to take an oral medication
  • transported by EMS to an ED

Exclusion Criteria:

  • unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
  • daily or every other day corticosteroid therapy
  • allergy to prednisolone or another corticosteroid
  • chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Fishe, MD 904-244-5812 Jennifer.fishe@jax.ufl.edu
Contact: Michelle Lott Michelle.Lott@jax.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962894
Other Study ID Numbers  ICMJE IRB201901351
1K23HL149991-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jennifer Fishe, MD University of Florida
PRS Account University of Florida
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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