Rapid Sequence Intubation at the Emergency Department

The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Emergency
• Intervention / Treatment: Device: Macintosh blade; Device: C-MAC videolaryngoscope

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zuerich, Switzerland, 8091
    • University Hospital Zuerich, Dept of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional endotracheal intubation; Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.	Device: Macintosh blade; conventional endotracheal intubation
Active Comparator: C-MAC; Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.	Device: C-MAC videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	defined as successful placement of endotracheal tube within the trachea and	10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: patients; departement; requiring Rapid Sequence Intubation (RSI)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: KEK Zurich 2014-0356