Intubation During Resuscitation

Intubation Clinical Trial

— IDR  

Official title:

Comparison of Four Types of Laryngoscope for Tracheal Intubation During Chest Compressions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277951
• Other study ID #: InternationalIRRE
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: October 27, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: International Institute of Rescue Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: The Central Register of Clinical Trials
• Study type: Observational

Clinical Trial Summary

The aim of the study was to compare time and success rates of four intubation devices ( in a cardiopulmonary scenario with uninterrupted chest compressions with a standardized manikin model.

The investigators hypothesized that fiberoscope laryngoscopes may improve success rates.

Description:

Devices using in study:

The Bonfils Intubation Fibrescope (BONFILS)(KARL STORZ Endovision, Inc., Charlton, MA, USA), The Video Rigid Flexing Laryngoscope (RIFL)( AI Medical Devices, Inc., Williamston, MI, USA), The C-MAC® S Video Laryngoscope Blade Mac#3(C-MAC®S) (KARL STORZ Endovision, Inc., Charlton, MA, USA) The Macintosh Laryngoscope Blade no. 3 (MAC) (LifeLine Medical, Inc., Brooksville, FL, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• experienced emergency personnel: nurses, paramedics

Exclusion Criteria:

• no experience in out-of-hospital emergency medicine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Intubation

Intervention

Device:
• The Bonfils Intubation Fibrescope
Effectiveness and time to successful intubation will be measured.
• The Video Rigid Flexing Laryngoscope
Effectiveness and time to successful intubation will be measured.
• The C-MAC® S Video Laryngoscope
Effectiveness and time to successful intubation will be measured.
• The Macintosh Laryngoscope
Effectiveness and time to successful intubation will be measured.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to successful intubation	The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.	Subjects complete study in 1 day	No
Primary	Success rate of ETI	The devices to be compared include (1) The Bonfils Intubation Fibrescope , (2) the Video Rigid Flexing Laryngoscope, (3) the C-MAC® S Video Laryngoscope, (4) the Macintosh Laryngoscope. Successful intubation will be measured in the seconds from insertion of an intubation device to the first manual ventilation of the mannequin's lungs.	Subjects complete study in 1 day	No