Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation

Airway Morbidity Clinical Trial

— SensaScope  

Official title:

Comparative Study Between SensaScope Intuboscope and McGrath Series 5 Videolaryngoscope to Tracheal Intubation: a Prospective Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348736
• Other study ID #: JohannesGUM
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 17, 2018
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: January 2018
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Biro P, Bättig 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. Epub 2006 Jun 1. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of different time for tracheal intubation	times for tracheal intubation, View of the glottic, experience in anesthesia	<2min