Respiratory FailureSHUTTLENCT04310384
'Single Hand Used inTubaTing Laryngoscope Evaluation' Study
A study testing ShuttleScope and MacIntosh Laryngoscope in people with Respiratory Failure and Cardiac Arrest, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Cardiac Arrest, Difficult Intubation
- What is being tested?
- ShuttleScope and MacIntosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medecine students from the Basque Country University (UPV/EHU)
Who cannot join
- Other operators different from the ones described above
- Previous experience with ShuttleScope videolaryngoscope
- informed consent non available
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)
Vitoria-Gasteiz, Alava, 01007
About this study
Official title: A Randomized Cross-Over Trial to Determine Whether the 'ShuttleScope® Laryngoscope is Inferior, Equal or Superior Compaired to Macintosh Laryngoscope to Perform Successful Endotracheal Intubation in a Manikin Model.
This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope
Read the detailed description
Following a 5 minutes workshop with an instructor structured demonstration and practice with both devices, the participants attempt intubation in a normal airway scenario with the Macintosh Laryngoscope and the novel ShuttleScope®, in a manikin model.
- Conditions
- Respiratory Failure, Cardiac Arrest, Difficult Intubation, Anesthesia Intubation Complication
- Being tested
- ShuttleScope, MacIntosh Laryngoscope
- Keywords
- Airway management, Videolaryngoscope, Mannequin, Endotracheal Intubation
- Medical subject headings
- Respiratory Insufficiency, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShuttleScopeDevice
Alternative intervention
MacIntosh LaryngoscopeDevice
Gold Standart
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Intubation, gold standart | Active comparator | Standart of Care with Macintosh laryngoscope Receives: Device: MacIntosh Laryngoscope |
| Alternative | Active comparator | Endotracheal Intubation with novel device Receives: Device: ShuttleScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Number of succesfull intubations after three attempts
Measured: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Time to Endotracheal Intubation
The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.
Measured: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Secondary outcomes (2)
Incidence of' oesophageal intubation
Number of oesophageal Intubations after three attempts
Measured: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Ease of insertion
Described by the operator and defined in a subjective visual analogue scale (VAS) from 0 to 10 for each of the devices (0 extremely difficult to 10 extremely easy)
Measured: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start22 Jan 2020
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Medrano Laporte, University of the Basque Country (UPV/EHU)
- Investigators
- Julio Miguel Alonso Babarro, Principal investigator, Airwaymedicalinnovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310384
- Sponsor's protocol ID
- 2019/259
- Acronym
- SHUTTLE
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Trial to Determine Whether the 'ShuttleScope® Laryngoscope is Inferior, Equal or Superior Compaired to Macintosh Laryngoscope to Perform Successful Endotracheal Intubation in a Manikin Model.
- ClinicalTrials.gov ID
- NCT04310384
- Acronym / sponsor ID
- SHUTTLE / 2019/259
- Conditions
- Respiratory Failure, Cardiac Arrest, Difficult Intubation, Anesthesia Intubation Complication
- Keywords
- Airway management, Videolaryngoscope, Mannequin, Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope
Detailed description
Following a 5 minutes workshop with an instructor structured demonstration and practice with both devices, the participants attempt intubation in a normal airway scenario with the Macintosh Laryngoscope and the novel ShuttleScope®, in a manikin model.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Intubation, gold standart | Active comparator | Device: MacIntosh LaryngoscopeStandart of Care with Macintosh laryngoscope |
| Alternative | Active comparator | Device: ShuttleScopeEndotracheal Intubation with novel device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medecine students from the Basque Country University (UPV/EHU)
Key exclusion criteria (3 listed)
- Other operators different from the ones described above
- Previous experience with ShuttleScope videolaryngoscope
- informed consent non available
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 |
|---|---|---|
| ShuttleScopeAlternative intervention | Device | Alternative |
| MacIntosh LaryngoscopeGold Standart | Device | Endotracheal Intubation, gold standart |
Primary outcome
Success Rate
Time frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Number of succesfull intubations after three attempts
Time to Endotracheal Intubation
Time frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.
2 secondary outcomes
Incidence of' oesophageal intubation
Time frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Ease of insertion
Time frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- AirwaymedicalinnovationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Julio Miguel Alonso Babarro principal investigator
Airwaymedicalinnovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShuttleScope and MacIntosh Laryngoscope in people with Respiratory Failure and Cardiac Arrest, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 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 Spain. 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?
Results are not available in the source record.
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?
Success Rate (time frame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time). The study lists 2 primary outcomes in all. 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 17 Mar 2020.