Rapid Sequence Intubation at the Emergency Department

Emergency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297113
• Other study ID #: KEK Zurich 2014-0356
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: March 24, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Emergency

Intervention

Device:
• Macintosh blade
conventional endotracheal intubation
• C-MAC videolaryngoscope

Locations

Country	Name	City	State
Switzerland	University Hospital Zuerich, Dept of Anesthesiology	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate	defined as successful placement of endotracheal tube within the trachea and	10 minutes	Yes
Secondary	time to intubation	defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2	10 minutes	Yes
Secondary	Laryngoscopic view	Cormack and Lehane Score	10 minutes	Yes
Secondary	Number of intubation attempts		10 minutes	Yes
Secondary	Unrecognized esophageal intubation		10 minutes	Yes
Secondary	Ease of intubation (1-5)	o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible	10 minutes	Yes
Secondary	Violations of the teeth	number of patients; teeth will be inspected for potential damage and documented accordingly	10 minutes	Yes
Secondary	Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)	number of patients, requiring alternate device	10 minutes	No
Secondary	Maximum drop of saturation	Spo2 will be measured continuously and documented accordingly	10 minutes	Yes