NCT02297113

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

November 13, 2014

Last Update Submit

March 24, 2016

Conditions

Emergency

Keywords

patientsdepartementrequiring Rapid Sequence Intubation (RSI)

Outcome Measures

Primary Outcomes (1)

  • Success Rate

    defined as successful placement of endotracheal tube within the trachea and

    10 minutes

Secondary Outcomes (8)

  • time to intubation

    10 minutes

  • Laryngoscopic view

    10 minutes

  • Number of intubation attempts

    10 minutes

  • Unrecognized esophageal intubation

    10 minutes

  • Ease of intubation (1-5)

    10 minutes

  • +3 more secondary outcomes

Study Arms (2)

conventional endotracheal intubation

ACTIVE COMPARATOR

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

Device: Macintosh blade

C-MAC

ACTIVE COMPARATOR

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

Device: C-MAC videolaryngoscope

Interventions

Macintosh bladeDEVICE

conventional endotracheal intubation

conventional endotracheal intubation
C-MAC videolaryngoscopeDEVICE
C-MAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zuerich, Dept of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 25903358BACKGROUND

  • 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.

    PMID: 27533711DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 21, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

CH(1)