NCT02348736

Brief Summary

A randomized controlled prospective study of laryngoscopy and intubation time comparing SensaScope and the McGrath® Series 5 video laryngoscope.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

January 12, 2015

Last Update Submit

January 17, 2018

Conditions

Keywords

airwayvideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • comparison of different time for tracheal intubation

    times for tracheal intubation, View of the glottic, experience in anesthesia

    <2min

Study Arms (2)

SensaScope

EXPERIMENTAL

Time for tracheal intubation with the SensaScope

Device: Time for tracheal intubation

McGrath Series 5

EXPERIMENTAL

Time for tracheal intubation with the McGrath Series 5

Device: Time for tracheal intubation

Interventions

In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve

McGrath Series 5SensaScope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 Years No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia

You may not qualify if:

  • Age \<18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification\> 3
  • situations where the possibility of accumulated gastric contents
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Related Publications (3)

  • Negishi Y, Shimada N, Urayama M, Niwa Y, Takeuchi M. [McGRATH MAC Videolaryngoscope: clinical assessment of its performance in 50 surgical patients]. Masui. 2014 Sep;63(9):1025-8. Japanese.

    PMID: 25255665BACKGROUND
  • Biro P. The SensaScope- A new hybrid video intubation stylet. Saudi J Anaesth. 2011 Oct;5(4):411-3. doi: 10.4103/1658-354X.87271.

  • Biro P, Battig U, Henderson J, Seifert B. First clinical experience of tracheal intubation with the SensaScope, a novel steerable semirigid video stylet. Br J Anaesth. 2006 Aug;97(2):255-61. doi: 10.1093/bja/ael135. Epub 2006 Jun 1.

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Marc Kriege, MD

    University JG, Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marc Kriege,MD

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations