Intubation With McGrath Video Laryngoscope and Boedeker I... | NCT01976546

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 29, 2013

First Submission Date that Met QC Criteria

Oct 29, 2013

First Posted Date

Nov 6, 2013Estimated

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

Oct 24, 2014

Last Update Posted Date

Oct 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways.

Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).

The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
airway		Patients with one or more predictors of diffucult airway	Device: Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps	Device	Patients will be intubated with the Mcgrath videolaryngoscope and a tracheal tube placed by Boedeker intubation foreceps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to intubation		within one day

Secondary Outcomes

Measure	Description	Time Frame
Sore throat		within 2 days
succesful intubation		within one day
Damage on teeth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for elective surgery
age over 18 or more
planned intubation with mcgrath videolaryngoscope
informed conscent obtained
patients are
patients shall be able to read and understand Danish

Exclusion Criteria:

Patients planned to awake intubation
stridor
hypoxia defined by saturation under 90% without oxygen supply
patients with oxygentreatment at home
patients that need a wired tube
patients that need a preshaped tube
patients that need crash induction
use of gastric tube

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

Patients with one or more predictors of difficult airway

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camilla Strøm, M.D	Dept. of anaesthesia, centre of head and orthopedics, Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesia, Centre of Head and Orthopedics 4231, Rigshospitalet		Copenhagen		2100	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques