Airway ManagementSATIATEDNCT03599687
Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics
An observational study of Airway Management and Intubation, Intratracheal, run by Yorkshire Ambulance Service NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management, Intubation, Intratracheal, Laryngoscopy
- What is being tested?
- Training in SALAD technique
- How many people
- 164 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 28 Feb 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18 and over
- HCPC registered paramedic employed by Yorkshire Ambulance Service
- Authorised to intubate within Yorkshire Ambulance Service
- No SALAD training in the last 3 months
Who cannot join
- Not an HCPC registered paramedic employed by Yorkshire Ambulance Service
- Not authorised to intubate within Yorkshire Ambulance Service
- Allergy to artificial 'vomit' ingredients
- Unwilling to provide consent
- SALAD training in the last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Yorkshire Ambulance Service NHS Trust
Wakefield, West Yorkshire, WF2 0XQ
About this study
Official title: Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED): A Randomised Controlled Manikin Study
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.
- Conditions
- Airway Management, Intubation, Intratracheal, Laryngoscopy, Vomiting
- Being tested
- Training in SALAD technique
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in SALAD techniqueOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre- and post-training as part of 2 hour study session
Secondary outcomes (2)
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.
Measured: seconds
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt
Measured: pre- and post-training as part of 2 hour study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Jul 2018
- Primary completion3 Dec 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yorkshire Ambulance Service NHS Trust
- Sponsor type
- Other government
- Collaborators
- College of Paramedics
- Responsible party
- Sponsor
- Investigators
- Richard Pilbery, Principal investigator, Yorkshire Ambulance Service NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599687
- Sponsor's protocol ID
- YASRD100
- Other IDs
- 245954
- Acronym
- SATIATED
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2018
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soiled Airway Tracheal Intubation and the Effectiveness of Decontamination by Paramedics (SATIATED): A Randomised Controlled Manikin Study
- ClinicalTrials.gov ID
- NCT03599687
- Acronym / sponsor ID
- SATIATED / YASRD100
- Conditions
- Airway Management, Intubation, Intratracheal, Laryngoscopy, Vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Yorkshire Ambulance Service NHS TrustOther government
- Collaborators
- College of Paramedics
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Aged 18 and over
- HCPC registered paramedic employed by Yorkshire Ambulance Service
- Authorised to intubate within Yorkshire Ambulance Service
- No SALAD training in the last 3 months
Key exclusion criteria (5 listed)
- Not an HCPC registered paramedic employed by Yorkshire Ambulance Service
- Not authorised to intubate within Yorkshire Ambulance Service
- Allergy to artificial 'vomit' ingredients
- Unwilling to provide consent
- SALAD training in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in SALAD techniqueThe 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. | Other | – |
Primary outcome
Difference in First-pass Intubation Success Rates Before and After SALAD Training
Time frame: pre- and post-training as part of 2 hour study session
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.
2 secondary outcomes
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.
Time frame: seconds
Difference in Success Rates Between Participants Who Have Two Post-training Intubation Attempts Versus Participants Who Only Have One Post-training Intubation Attempt
Time frame: pre- and post-training as part of 2 hour study session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Pilbery principal investigator
Yorkshire Ambulance Service NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and Intubation, Intratracheal, run by Yorkshire Ambulance Service NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in First-pass Intubation Success Rates Before and After SALAD Training (time frame: pre- and post-training as part of 2 hour study session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.