Rapid Sequence Intubation at the Emergency Department

NCT ID: NCT02297113

Last Updated: 2016-03-25

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect.

If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups

1. C-MAC Videolaryngoscope in appropriate size
2. conventional endotracheal intubation using Macintosh Blade in appropriate size

Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.

Detailed Description

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Conditions

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Emergency

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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conventional endotracheal intubation

Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.

Group Type ACTIVE_COMPARATOR

Macintosh blade

Intervention Type DEVICE

conventional endotracheal intubation

C-MAC

Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.

Group Type ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type DEVICE

Interventions

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Macintosh blade

conventional endotracheal intubation

Intervention Type DEVICE

C-MAC videolaryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring emergency Rapid Sequence Intubation at the emergency department
* Male and Female subjects 18 years to 99 years of age
* Written confirmation by a physician not involved in this study
* Written informed consent by the participant (obtained afterwards)
* Patient not showing remarkable rejection in participation in this study

Exclusion Criteria

* Maxilla-Facial trauma
* Immobilized cervical spine
* Indication for fiberoptic guided intubation (known difficult airway)
* Ongoing Cardio-Pulmonary-Resuscitation (CPR)
* Involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion
* Severe or immediately life-treating injury requiring immediate medical treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zuerich, Dept of Anesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Sulser S, Ubmann D, Brueesch M, Goliasch G, Seifert B, Spahn DR, Ruetzler K. The C-MAC videolaryngoscope compared with conventional laryngoscopy for rapid sequence intubation at the emergency department: study protocol. Scand J Trauma Resusc Emerg Med. 2015 Apr 24;23:38. doi: 10.1186/s13049-015-0119-x.

Reference Type BACKGROUND
PMID: 25903358 (View on PubMed)

Sulser S, Ubmann D, Schlaepfer M, Brueesch M, Goliasch G, Seifert B, Spahn DR, Ruetzler K. C-MAC videolaryngoscope compared with direct laryngoscopy for rapid sequence intubation in an emergency department: A randomised clinical trial. Eur J Anaesthesiol. 2016 Dec;33(12):943-948. doi: 10.1097/EJA.0000000000000525.

Reference Type DERIVED
PMID: 27533711 (View on PubMed)

Other Identifiers

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KEK Zurich 2014-0356

Identifier Type: -

Identifier Source: org_study_id

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