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| ID | Type | Description | Link |
|---|---|---|---|
| 245954 | Other Identifier | IRAS |
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| Name | Class |
|---|---|
| College of Paramedics | UNKNOWN |
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In more than one-in-five cases of out-of-hospital cardiac arrest, airways are blocked by vomit and blood. Sometimes, paramedics cannot clear the airway using methods they have been taught. If the airway cannot be cleared, the patient will die.
Usually, these patients will have a breathing tube placed into their windpipe (intubation), as this provides protection from vomit and blood. To do this, the paramedic needs to be able to see the entrance to the windpipe.
A new method of clearing the airway called SALAD has been used in patients to help insert a breathing tube, but it is not known whether the method can help paramedics. This study will use a manikin to see if paramedics can insert a breathing tube more often on their first attempt, using SALAD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training in SALAD technique | Other | The training session will be delivered, and will take around 45 minutes to complete, including time for participant practice. The training intervention will adopt the Advanced Life Support Group/Resuscitation Council 4-stage approach of skills teaching, and is comprised of: A real-time demonstration of the SALAD technique by the researcher; A repeated demonstration with an explanation of the rationale of the steps taken when performing SALAD (not real-time); Another demonstration of the SALAD technique conducted by the researcher, but guided by one of the participants; An attempt by the same participant who guided the researcher in the previous step, followed by a practice attempt by the other participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in First-pass Intubation Success Rates Before and After SALAD Training | This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training. | pre- and post-training as part of 2 hour study session |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart. | seconds | |
| Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be NHS staff who are employed by Yorkshire Ambulance Service NHS Trust, and who are Health and Care Professions Council (HCPC) registered paramedics.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Pilbery | Yorkshire Ambulance Service NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yorkshire Ambulance Service NHS Trust | Wakefield | West Yorkshire | WF2 0XQ | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group AAB | In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts. |
| FG001 | Group ABB | Participants randomised into making one pre-training and two post-training intubation attempts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group AAB | In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in First-pass Intubation Success Rates Before and After SALAD Training | This measure is a comparison of Group AAB's first-pass intubation success rate, using an attempt which occurred before SALAD training, and Group ABB's intubation success rate, using an intubation attempt that occurred after SALAD training. | Posted | Count of Participants | Participants | pre- and post-training as part of 2 hour study session |
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Adverse events were monitored over the course of each study session, which lasted approximately 2 hours.
Adverse events are reported to the service via the DATIX incident reporting scheme and the sponsor is notified immediately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group AAB | In order to adjust for improvements in participant performance that might arise from repeated attempts at intubation, beyond that of the SALAD training itself, paramedics were randomised into one of two group. In AAB, participants randomised into making two pre-training and one post-training intubation attempts. |
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Manikin study Vomit did not contain solid material and was not odorous Participants not blinded from allocation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Pilbery | Yorkshire Ambulance Service NHS Trust | +447463734823 | r.pilbery@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2018 | Jul 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| pre- and post-training as part of 2 hour study session |
| Group ABB |
Participants randomised into making one pre-training and two post-training intubation attempts. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Intubation attempts in past 12 months | Median | Inter-Quartile Range | attempts |
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| Successful intubation attempts in past 12 months | Median | Inter-Quartile Range | attempts |
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| Years as a paramedic | Median | Inter-Quartile Range | years |
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| Awareness of SALAD technique | Count of Participants | Participants |
|
Participants randomised into making one pre-training and two post-training intubation attempts. |
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| Secondary | Difference Between Mean Time Taken (in Seconds) to Perform a Successful Intubation on the First- Attempt, Before and After SALAD Training Approximately 30 Minutes Apart. | Posted | Mean | Standard Error | seconds | seconds |
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| Secondary | Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt | Posted | Count of Participants | Participants | pre- and post-training as part of 2 hour study session |
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| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Group ABB | Participants randomised into making one pre-training and two post-training intubation attempts. | 0 | 82 | 0 | 82 | 0 | 82 |
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