Clinical trial NCT02297113: Rapid Sequence Intubation at the Emergency Department
Official title: The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency
Keywords: patients
departement
requiring Rapid Sequence Intubation (RSI)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success Rate
timeFrame: 10 minutes
Secondary outcomes:
measure: time to intubation
timeFrame: 10 minutes
measure: Laryngoscopic view
timeFrame: 10 minutes
measure: Number of intubation attempts
timeFrame: 10 minutes
measure: Unrecognized esophageal intubation
timeFrame: 10 minutes
measure: Ease of intubation (1-5)
timeFrame: 10 minutes
measure: Violations of the teeth
timeFrame: 10 minutes
measure: Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
timeFrame: 10 minutes
measure: Maximum drop of saturation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Zuerich
country: Switzerland
facility: University Hospital Zuerich, Dept of Anesthesiology
Study officials:
References:
citation: 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.
citation: 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.