Prehospital Airway Management in Patients With Cardiac Arrest Clinical Trial
— SAVEOfficial title:
A RCT on Supraglottic Airway Versus Endotracheal Intubation in OHCA (SAVE)
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.
| Status | Not yet recruiting |
| Enrollment | 852 |
| Est. completion date | December 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The rate of survival to discharge of OHCAs resuscitated by non-paramedic (airway device: all SGA) | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Other | The interaction between age and airway management | Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Other | The interaction between bystander CPR and airway management | Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Other | The interaction between shockable rhythms and airway management | Deciphering interactions in logistic regression model with variables of standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Primary | survival to admission | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Secondary | any ROSC | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Secondary | survival to discharge | Measurement of outcome by standard Utstein OHCA registry system in Taipei City | One month after event | No |
| Secondary | favorable neurologic outcome | 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 |
One month after event | No |