Back to results

Effectiveness of Pediatric Intubation (PETI)

Primary Purpose

Cardiac Arrest

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Venner

Miller

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Give voluntary consent to participate in the study
minimum 1 year of work experience in nursing

Exclusion Criteria:

Not meet the above criteria
Wrist or Low back diseases

Sites / Locations

International Institute of Rescue Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intubation without chest compressions

Intubation with uninterrupted chest compressions

Arm Description

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Endotracheal intubation of pediatric mannikin during resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).

Outcomes

Primary Outcome Measures

Success of intubation

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

Secondary Outcome Measures

Intubation time

time in seconds required for a successful intubation attempt

POGO score

self-reported percentage of glottis opening (POGO) score

Cormack-Lehane grading

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

Full Information

NCT ID

NCT02289651

First Posted

November 10, 2014

Last Updated

November 12, 2014

Sponsor

International Institute of Rescue Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT02289651

Brief Title

Effectiveness of Pediatric Intubation

Acronym

PETI

Official Title

Comparison of the Venner(TM) A.P. Advance(TM) With the Macintosh Laryngoscope for Emergency Intubation in a Standardized Airway Manikin With and Without Chest Compressions by Nurses. A Randomized, Controlled Crossover Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

We hypothesized that the Venner videolaryngoscope (A.P. Advance™) is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the Venner videolaryngoscope (A.P. Advance™) and MIL laryngoscopes in child resuscitation with and without CC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

intubation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intubation without chest compressions

Arm Type

Experimental

Arm Description

Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.

Arm Title

Intubation with uninterrupted chest compressions

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Venner

Other Intervention Name(s)

The Venner A.P. Advance Video Laryngoscope

Intervention Description

Video-laryngoscopy

Intervention Type

Device

Intervention Name(s)

Miller

Other Intervention Name(s)

Miller Laryngoscope

Intervention Description

Direct-Laryngoscopy

Primary Outcome Measure Information:

Title

Success of intubation

Description

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

Time Frame

1 MONTH

Secondary Outcome Measure Information:

Title

Intubation time

Description

time in seconds required for a successful intubation attempt

Time Frame

1 MONTH

Title

POGO score

Description

self-reported percentage of glottis opening (POGO) score

Time Frame

1 MONTH

Title

Cormack-Lehane grading

Description

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

Time Frame

1 MONTH

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Give voluntary consent to participate in the study minimum 1 year of work experience in nursing Exclusion Criteria: Not meet the above criteria Wrist or Low back diseases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrzej Kurowski

Phone

+48500186225

andrzejkurowski987@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lukasz Szarpak

Organizational Affiliation

Institute of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Institute of Rescue Research and Education

City

Warsaw

State/Province

Masovia

ZIP/Postal Code

03-122

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lukasz Szarpak

First Name & Middle Initial & Last Name & Degree

Andrzej Kurowski, PhD, MD

First Name & Middle Initial & Last Name & Degree

Lukasz Czyżewski

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Pediatric Intubation

We'll reach out to this number within 24 hrs