Rapid Sequence Intubation at the Emergency Department

Not Applicable

Completed

• Conditions: Emergency
• Interventions: Device: Macintosh blade; Device: C-MAC videolaryngoscope

• Registration Number: NCT02297113
• Lead Sponsor: University of Zurich

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional endotracheal intubation	Macintosh blade	Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.
C-MAC	C-MAC videolaryngoscope	Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.

Primary Outcome Measures

Name	Time	Method
Success Rate	10 minutes	defined as successful placement of endotracheal tube within the trachea and

Secondary Outcome Measures

Name	Time	Method
time to intubation	10 minutes	defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2
Laryngoscopic view	10 minutes	Cormack and Lehane Score
Number of intubation attempts	10 minutes
Unrecognized esophageal intubation	10 minutes
Ease of intubation (1-5)	10 minutes	o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible
Violations of the teeth	10 minutes	number of patients; teeth will be inspected for potential damage and documented accordingly
Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)	10 minutes	number of patients, requiring alternate device
Maximum drop of saturation	10 minutes	Spo2 will be measured continuously and documented accordingly

Trial Locations

Locations (1)

University Hospital Zuerich, Dept of Anesthesiology; 🇨🇭 Zuerich, Switzerland