Safety and Efficacy of Cleverscope. A New Medical Device... | NCT03902704

Studies
Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation

NCT03902704

Sponsor

Hospital General Universitario de Valencia

Status

Unknown status

Last Update Posted

May 16, 2022Actual

Enrollment

134Estimated

Phase

Not Applicable

Conditions

Anesthesia Intubation Complication
Difficult Intubation

Interventions

Cleverscope
Laryngoscope / Videolaryngoscope C-MAC® Storz

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Mar 31, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2022

Last Update Posted Date

May 16, 2022Actual

Name	Class
FIPSE	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cleverscope	Experimental	Cleverscope is a new videolaryngoscope used for tracheal intubation. in this group we use this device to intubate participants.	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	Device: Laryngoscope / Videolaryngoscope C-MAC® Storz

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cleverscope	Device	the device is used in patients without difficult airways predictors	Cleverscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)	degree of glotis visualization	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
First attempt intubation success rate	the rate of traqueal tube pass through vocal cords at first attemps.	intraoperative
overall success intubation rate with same device	it could include more attempts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

part 1: Scheduled Patients for any kind of surgery with general anesthesia with tracheal intubation without predictors of difficult intubation :
1. Arne Test < 10
2. 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 :
1. Arne Test > 10
2. cervical circunference / tyromental distance > 4.

Exclusion Criteria:

no mouth openning >2cm
required use of awake fiberscope por tracheal intubation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucas Rovira, PhD	Contact	+34659276476		lucasrovira@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucas Rovira	Recruiting	La Pobla de Vallbona	Valencia	46185	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020704	Laryngoscopes

Ancestor Terms

ID	Term
D019723	Endoscopes
D019719	Diagnostic Equipment
D004864	Equipment and Supplies
D013523	Surgical Equipment

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.