DLETI: Double Lumen Tube Intubation

• Sponsor: International Institute of Rescue Research and Education (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02295657
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 121.8

Study Details

Study Description

Brief Summary

The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Intubation; Cardiac Arrest	Device: standard double-lumen tube; Device: VivaSight Double Lumen Tube	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ETI intubation endotracheal intubation in manikin	Device: standard double-lumen tube; intubation using standard double-lumen tube; Device: VivaSight Double Lumen Tube; intubation using VivaSight Double Lumen Tube

Outcome Measures

Primary Outcome Measures

1. Success of intubation [1 day]

   effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

Secondary Outcome Measures

1. Intubation time [1 day]

   time in seconds required for a successful intubation attempt

2. Cormack-Lehane grading [1 day]

   self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

3. Preferred ETI device [1day]

   participants were asked which method of ETI they would prefer in a real-life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• give voluntary consent to participate in the study

• minimum 1 year of work experience in emergency medicine

• experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

• not meet the above criteria

• wrist or low back diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Institute of Rescue Research and Education	Warsaw	Masovia	Poland	03-122

Sponsors and Collaborators

• International Institute of Rescue Research and Education

Investigators

• Principal Investigator: Lukasz Szarpak, Institute of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
• ClinicalTrials.gov Identifier: NCT02295657
• Other Study ID Numbers: ETI/2014/43
• First Posted: Nov 20, 2014
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Nov 20, 2014