Macintosh and D-Blade® in Simulated Difficult Airway

NCT ID: NCT03403946

Last Updated: 2018-01-23

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-01

Study Completion Date

2012-08-31

Brief Summary

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In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Detailed Description

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Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.

An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.

Therefore, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Conditions

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Difficult Intubation Cervical Injury Spine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Intervention

All patients received the same treatment.

1. Laryngscopy with C-MAC PM + Macintosh blade
2. Laryngscopy with C-MAC PM + D-Blade
3. Intubation with C-MAC PM + D-Blade

Group Type EXPERIMENTAL

Macintosh blade

Intervention Type DEVICE

Laryngoscopy with C-MAC PM in combination with Macintosh blade

D-Blade

Intervention Type DEVICE

Laryngoscopy with C-MAC PM in combination with D-Blade

Intubation

Intervention Type DEVICE

Intubation with C-MAC PM in combination with D-Blade

Interventions

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Macintosh blade

Laryngoscopy with C-MAC PM in combination with Macintosh blade

Intervention Type DEVICE

D-Blade

Laryngoscopy with C-MAC PM in combination with D-Blade

Intervention Type DEVICE

Intubation

Intubation with C-MAC PM in combination with D-Blade

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring general anesthesia for orthopedic surgery

Exclusion Criteria

* known or expected difficult airway
* undergoing urgent or emergent surgery
* non-fasted
* American Society of Anesthesiology Class (ASA) IV-VI
* no consent for participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. med. Florian Raimann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haitham Mutlak, Dr. med.

Role: STUDY_DIRECTOR

Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Locations

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University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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Raimann FJ, Dietze PE, Cuca CE, Meininger D, Kessler P, Byhahn C, Gill-Schuster D, Zacharowski K, Mutlak H. Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM(R) with Macintosh Blade and D-Blade(R) in a Simulated Difficult Airway. Emerg Med Int. 2019 Apr 1;2019:1067473. doi: 10.1155/2019/1067473. eCollection 2019.

Reference Type DERIVED
PMID: 31065384 (View on PubMed)

Other Identifiers

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126/11

Identifier Type: -

Identifier Source: org_study_id

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