Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade... | NCT04759300

Studies
Effectiveness of C-MAC Video-stylet Versus C-MAC D- Blade Video-laryngoscope for Tracheal Intubation

NCT04759300

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Jun 1, 2022Actual

Enrollment

160Estimated

Phase

Not Applicable

Conditions

Difficult Mask Ventilation
Difficult Intubation

Interventions

C-MAC VS
C-MAC VL D -blade

Countries

Egypt

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

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

May 2022Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Feb 15, 2021

First Submission Date that Met QC Criteria

Feb 15, 2021

First Posted Date

Feb 18, 2021Actual

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 29, 2022

Last Update Posted Date

Jun 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

rehab zayed, Assisstant Professor of Anesthesia, Alexandria UniversityPrincipal Investigator

Lead Sponsor

Alexandria UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Videolaryngoscopy provides a better laryngeal view and do not need airway alignment for tracheal intubation.

Detailed Description

The C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation. C-MAC-VS has no lumens so it's very easy to clean and it can accommodates a size ETT 6.0 and greater.

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

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group C-MAC VS	Active Comparator	patients undergoing tracheal intubation using the C-MAC VS.	Device: C-MAC VS
Group C-MAC VL D -blade	Placebo Comparator	patients undergoing intubation using the C-MAC VL D-blade.	Device: C-MAC VL D -blade

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-MAC VS	Device	patients undergoing tracheal intubation using the C-MAC VS	Group C-MAC VS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of intubation procedure	assess duration of intubation procedure by using C-MAC VS versus C-MAC D-blade in patients with anticipated difficult airway.	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with BMI ≥ 30 kg/m2,
presence of any predictors of difficult intubation;
Mallampati score > =3;
inter-incisor distance < 3 cm;
thyromental distance < 6 cm;
neck extension < 80°from neck flexion;
cervical spine instability; history of difficult endotracheal intubation or difficult mask ventilation

Exclusion Criteria:

patients have increased risk of pulmonary aspiration;
have significant medical diseases in term of cardiac, respiratory, hepatic, renal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
rehab A. Abd Elaziz, Ass.Prof.	Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
rehab Abd Elaziz		Alexandria		000000	Egypt

Intervention Model Description

The patients will be randomly assigned into two equal groups using computer-generated randomization technique. Group C-MAC VS (VS group) included patients undergoing tracheal intubation using the C-MAC VS. Group C-MAC VL D -blade (D group) included patients undergoing intubation using the C-MAC VL D-blade.