Comparison of SensaScope Intuboscope and McGrath Series 5 for Endotracheal Intubation

NCT ID: NCT02348736

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Airway Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SensaScope

Time for tracheal intubation with the SensaScope

Group Type EXPERIMENTAL

Time for tracheal intubation

Intervention Type DEVICE

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

McGrath Series 5

Time for tracheal intubation with the McGrath Series 5

Group Type EXPERIMENTAL

Time for tracheal intubation

Intervention Type DEVICE

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

Interventions

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Time for tracheal intubation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Marc Kriege, MD

Marc Kriege,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Kriege, MD

Role: PRINCIPAL_INVESTIGATOR

University JG, Mainz

Locations

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

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 25255665 (View on PubMed)

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.

Reference Type RESULT
PMID: 22144929 (View on PubMed)

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.

Reference Type RESULT
PMID: 16740606 (View on PubMed)

Other Identifiers

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JohannesGUM

Identifier Type: -

Identifier Source: org_study_id

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