Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bro... | NCT04759287

Studies
Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation

NCT04759287

Sponsor

rehab zayed

Status

Unknown status

Last Update Posted

Feb 18, 2021Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Difficult Mask Ventilation
Difficult Intubation

Interventions

C-MAC VS
flexible fibreoptic bronchoscope

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

Feb 2021

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

Nov 20, 2020Actual

Primary Completion Date

May 20, 2021Estimated

Completion Date

Jun 1, 2021Estimated

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

Feb 15, 2021

Last Update Posted Date

Feb 18, 2021Actual

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

C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

Detailed Description

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.

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VS group	Active Comparator	include patients undergoing awake intubation using the C-MAC VS	Device: C-MAC VS
FOB group	Placebo Comparator	will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.	Device: flexible fibreoptic bronchoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-MAC VS	Device	The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS	VS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the time required for a wake intubation	assess the time required for a wake intubation using C-MAC VS versus FOB 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. The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS. The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.