Anesthesia Intubation ComplicationNCT03902704
Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation
A study testing Cleverscope and Laryngoscope / Videolaryngoscope C-MAC® Storz in people with Anesthesia Intubation Complication and Difficult Intubation, run by Hospital General Universitario de Valencia at 1 site in Spain.
Trial summary
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Intubation Complication, Difficult Intubation
- What is being tested?
- Cleverscope and Laryngoscope / Videolaryngoscope C-MAC® Storz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 1 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :
- Arne Test < 10
- cervical circunference / tyromental distance < 4.
- part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation :
- Arne Test > 10
- cervical circunference / tyromental distance > 4.
Who cannot join
- no mouth openning >2cm
- required use of awake fiberscope por tracheal intubation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Lucas Rovira
La Pobla de Vallbona, Valencia, 46185
Lucas Rovira, PhD, +34659276476, lucasrovira@gmail.com
Lucas Rovira, PhD
About this study
Official title: Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.
Read the detailed description
the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation.
part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.
- Being tested
- Cleverscope, Laryngoscope / Videolaryngoscope C-MAC® Storz
- Keywords
- videolaryngoscopy, tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleverscopeDevice
the device is used in patients without difficult airways predictors
Laryngoscope / Videolaryngoscope C-MAC® StorzDevice
the device is used in patients with difficult airways predictors
| Study group | Role | What they receive |
|---|---|---|
| Cleverscope | Experimental | Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants. Receives: Device: Cleverscope |
| Laryngoscope / Videolaryngoscope C-MAC® Storz | Active comparator | in this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants Receives: Device: Laryngoscope / Videolaryngoscope C-MAC® Storz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)
degree of glotis visualization
Measured: intraoperative
Secondary outcomes (4)
First attempt intubation success rate
the rate of traqueal tube pass through vocal cords at first attemps.
Measured: intraoperative
overall success intubation rate with same device
it could include more attempts
Measured: intraoperative
time to success
time wasted from device inserted into mouth to inflate tracheal tube
Measured: intraoperative
complications rate
register complications during intubation or due device usage. like hemorrage, mucosal laceration,
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- part 1 its single group of participants(50 patients without difficult airways predictors). this group receives direct laringoscopy with common laryngoscope (L) during the initial phase of the trial, followed by videolaryngoscope (VL) Cleverscope (used for intubation) during a later phase. part 2 of the study its two-by-two cross-over assignment involves two groups of participants(84 patients with difficult airways predictors). One group receives VL with C-MAC during the initial phase of the trial, followed by Cleverscope for intubation during a later phase. The other group receives VL with Cleverscope during the initial phase, followed by C-MAC VL used for intubation. So during the part 2 trial, participants "cross over" to the other videolaringoscopy.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- FIPSE
- Responsible party
- Principal investigator, Lucas Rovira, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902704
- Sponsor's protocol ID
- Rov-Clever-2017
- Status last verified
- May 2022
- First submitted
- 31 Mar 2019
- Last updated
- 16 May 2022
- 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 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
- ClinicalTrials.gov ID
- NCT03902704
- Acronym / sponsor ID
- Rov-Clever-2017
- Keywords
- videolaryngoscopy, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Hospital General Universitario de ValenciaUniversity, hospital or other
- Collaborators
- FIPSE
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Apr 2019 (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.
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.
Detailed description
the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation.
part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- part 1 its single group of participants(50 patients without difficult airways predictors). this group receives direct laringoscopy with common laryngoscope (L) during the initial phase of the trial, followed by videolaryngoscope (VL) Cleverscope (used for intubation) during a later phase. part 2 of the study its two-by-two cross-over assignment involves two groups of participants(84 patients with difficult airways predictors). One group receives VL with C-MAC during the initial phase of the trial, followed by Cleverscope for intubation during a later phase. The other group receives VL with Cleverscope during the initial phase, followed by C-MAC VL used for intubation. So during the part 2 trial, participants "cross over" to the other videolaringoscopy.
| Arm | Type | Receives |
|---|---|---|
| Cleverscope | Experimental | Device: CleverscopeCleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants. |
| Laryngoscope / Videolaryngoscope C-MAC® Storz | Active comparator | Device: Laryngoscope / Videolaryngoscope C-MAC® Storzin this group we use a standart comercial device for intubation (laryngoscope or C-MAC) to intubate participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :
- part 2: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation with predictors of difficult intubation :
Key exclusion criteria (2 listed)
- no mouth openning >2cm
- required use of awake fiberscope por tracheal intubation
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 |
|---|---|---|
| Cleverscopethe device is used in patients without difficult airways predictors | Device | Cleverscope |
| Laryngoscope / Videolaryngoscope C-MAC® Storzthe device is used in patients with difficult airways predictors | Device | Laryngoscope / Videolaryngoscope C-MAC® Storz |
Primary outcome
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)
Time frame: intraoperative
degree of glotis visualization
4 secondary outcomes
First attempt intubation success rate
Time frame: intraoperative
overall success intubation rate with same device
Time frame: intraoperative
time to success
Time frame: intraoperative
complications rate
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleverscope and Laryngoscope / Videolaryngoscope C-MAC® Storz in people with Anesthesia Intubation Complication and Difficult Intubation, run by Hospital General Universitario de Valencia 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 6 inclusion and 2 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 16 May 2022. 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?
Contact Lucas Rovira, PhD (+34659276476, lucasrovira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate) (time frame: intraoperative). 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 16 May 2022.