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Trial record 10 of 47 for:    intubation | cardiac arrest

A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)

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ClinicalTrials.gov Identifier: NCT02967952
Recruitment Status : Not yet recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
In this 3-year successive research plan, investigators will conduct a prehospital randomized controlled trial to address the following question: In adult patients with non-traumatic cause of out-of-hospital cardiac arrest resuscitated by emergency medical technician (paramedic level) in the prehospital setting, will receiving endotracheal tube intubation cause a better chance of sustained recovery of spontaneous circulation and other survival outcomes like neurologically favorable status, comparing to those who receiving supraglottic airway device.

Condition or disease Intervention/treatment Phase
Prehospital Airway Management in Patients With Cardiac Arrest Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 852 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)
Study Start Date : November 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: supraglottic airway (SGA)
Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of supraglottic airway (SGA).
Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
already being described above

Active Comparator: endotracheal intubation (ETI)
Adult patients with non-trauma causes of OHCA who are resuscitated by emergency medical technician paramedic (EMTP) in the prehospital setting and received airway management of endotracheal intubation (ETI).
Device: supraglottic airway (SGA) V.S. endotracheal intubation (ETI)
already being described above




Primary Outcome Measures :
  1. survival to admission [ Time Frame: One month after event ]
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City


Secondary Outcome Measures :
  1. any ROSC [ Time Frame: One month after event ]
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City

  2. survival to discharge [ Time Frame: One month after event ]
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City

  3. favorable neurologic outcome [ Time Frame: One month after event ]

    Favorable neurologic outcome was defined by CPC (cerebral performance category) 1 and 2.

    Measurement of outcome by standard Utstein OHCA registry system in Taipei City



Other Outcome Measures:
  1. The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA) [ Time Frame: One month after event ]
    Measurement of outcome by standard Utstein OHCA registry system in Taipei City

  2. The interaction between age and airway management [ Time Frame: One month after event ]
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City

  3. The interaction between bystander CPR and airway management [ Time Frame: One month after event ]
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City

  4. The interaction between shockable rhythms and airway management [ Time Frame: One month after event ]
    Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • out-of-hospital cardiac arrest; OHCA
  • age ≥ 20 years old
  • non-traumatic cause

Exclusion Criteria:

  • signs of obvious death, eg. decapitation or rigor mortis
  • theoretically not suitable for ETI, eg. facial deformity or third-trimester pregnancy
  • theoretically not suitable for SGA, eg. foreign-body airway obstruction
  • with "do not attempt resuscitation" order
  • the occurrence of OHCA during ambulance transport
  • ROSC in the field with clear consciousness and spontaneous adequate ventilation
  • advanced airway being established before the arrival of paramedics

Information from the National Library of Medicine

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): NCT02967952


Contacts
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Contact: Wen-Chu Chiang, MD, PhD. +886-2-23123456 ext 62831 drchiang.tw@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wen-Chu Chiang, MD, PhD. Emergency Dept, National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02967952     History of Changes
Other Study ID Numbers: 201606047RINA
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by National Taiwan University Hospital:
out-of-hospital cardiac arrest (OHCA)
supraglottic airway (SGA)
endotracheal intubation (ETI)
emergency medical system (EMS)
Supraglottic Airway Versus Endotracheal tube (SAVE)
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases