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

NCT03902704 | Unknown

• 1 other identifier: Rov-Clever-2017
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.

Conditions

Anesthesia Intubation Complication; Difficult Intubation

Keywords

videolaryngoscopy; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Cormack-Lehane Glotic visualization scale (I(complete view, easy to intubate)-IV(no view, imposible to intubate)

  degree of glotis visualization

  intraoperative

Secondary Outcomes (4)

• First attempt intubation success rate

  intraoperative

• overall success intubation rate with same device

  intraoperative

• time to success

  intraoperative

• complications rate

  intraoperative

Study Arms (2)

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

Cleverscope DEVICE

the device is used in patients without difficult airways predictors

Cleverscope

Laryngoscope / Videolaryngoscope C-MAC® Storz DEVICE

the device is used in patients with difficult airways predictors

Laryngoscope / Videolaryngoscope C-MAC® Storz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead
• FIPSE: collaborator

Study Sites (1)

Lucas Rovira

La Pobla de Vallbona, Valencia, 46185, Spain

RECRUITING

MeSH Terms

Interventions

Laryngoscopes

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Lucas Rovira, PhD

CONTACT

+34659276476; lucasrovira@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 4, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)