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Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Completed
CT.gov ID
NCT02348736
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
3
Duration (Months)
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Time for tracheal intubation
 N/A

Detailed Description

The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to semi-rigid stylet. An national, mono center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® Series 5 versus SensaScope in adult patients under general anaesthesia.

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: SensaScope

Time for tracheal intubation with the SensaScope

Device: Time for tracheal intubation
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
Experimental: McGrath Series 5

Time for tracheal intubation with the McGrath Series 5

Device: Time for tracheal intubation
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve

Outcome Measures

Primary Outcome Measures

  1. comparison of different time for tracheal intubation [<2min]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University Mainz Rhineland-Palatinate Germany D55131

Sponsors and Collaborators

  • Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Marc Kriege, MD, University JG, Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marc Kriege, MD, Marc Kriege,MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT02348736
Other Study ID Numbers:
  • JohannesGUM
First Posted:
Jan 28, 2015
Last Update Posted:
Jan 19, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Marc Kriege, MD, Marc Kriege,MD, Johannes Gutenberg University Mainz
airway
videolaryngoscope

Study Results

No Results Posted as of Jan 19, 2018