CompletedNCT02297113Updated Mar 25, 2016

Rapid Sequence Intubation at the Emergency Department

An interventional study of Macintosh blade and C-MAC videolaryngoscope in Emergency, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-25.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 150
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

C-MAC Videolaryngoscope in appropriate size
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.

Conditions studied

Emergency

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Emergencies 1,692

Keywords

patients
departement
requiring Rapid Sequence Intubation (RSI)

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 150 is close to the median of 145 across 931 interventional studies indexed under Emergencies.

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Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 150 participants (actual)

Study arms

Active comparator
conventional endotracheal intubation
Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.
Device: Macintosh blade
Active comparator
C-MAC
Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.
Device: C-MAC videolaryngoscope

Interventions

DeviceMacintosh blade
conventional endotracheal intubation
DeviceC-MAC videolaryngoscope

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

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

References and documents

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. PubMed 25903358 ↗
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. PubMed 27533711 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02297113
Lead sponsor: University of Zurich
Responsible party: Sponsor
First posted: Nov 21, 2014
Start date: Nov 2014
Primary completion: Dec 2015
Completion: Dec 2015
Last update: Mar 25, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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