Back to results

Pediatric Intubation Among Nursing

Primary Purpose

Cardiac Arrest, Intubation, Endotracheal

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

MIL

CoPilot

About this trial

This is an interventional treatment trial for Cardiac Arrest

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

Child ETI with chest compressions

Child ETI without chest compressions

Arm Description

endotracheal intubation (ETI) during child mannikin 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.).

Endotracheal intubation of child mannikin during resuscitation without chest compressions.

Outcomes

Primary Outcome Measures

Success of intubation

effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices.

Secondary Outcome Measures

Time to intubation

time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.If the examinee failed at all attempts, the case was excluded from the time calculations.

Full Information

NCT ID

NCT02291640

First Posted

November 11, 2014

Last Updated

November 11, 2014

Sponsor

International Institute of Rescue Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT02291640

Brief Title

Pediatric Intubation Among Nursing

Official Title

Coparison of Miller and CoPilot Laryngoscopes for Intubation by Nurses During Child Chest Compression. A Manikin Study

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

The aim of this study was to compare time, success rates of video laryngoscope and direct laryngoscope for the emergency intubation with an immobilized cervical spine in a standardized pediatric manikin model.

6. Conditions and Keywords

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

Cardiac Arrest, Intubation, Endotracheal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Child ETI with chest compressions

Arm Type

Experimental

Arm Description

Arm Title

Child ETI without chest compressions

Arm Type

Experimental

Arm Description

Endotracheal intubation of child mannikin during resuscitation without chest compressions.

Intervention Type

Device

Intervention Name(s)

MIL

Other Intervention Name(s)

Miller laryngoscope

Intervention Description

direct laryngoscopy

Intervention Type

Device

Intervention Name(s)

CoPilot

Other Intervention Name(s)

CoPilot VideoLaryngoscope

Intervention Description

video laryngoscopy

Primary Outcome Measure Information:

Title

Success of intubation

Description

effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Time to intubation

Description

Time Frame

1 day

Other Pre-specified Outcome Measures:

Title

Cormack-Lehan scale

Description

self reported Cormack-Lehan scale during intubation

Time Frame

1 day

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

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

Lukasz Szarpak

Phone

+48500186225

lukasz.szarpak@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

Phone

+48500186225

lukasz.szarpak@gmail.com

First Name & Middle Initial & Last Name & Degree

Lukasz Szarpak

First Name & Middle Initial & Last Name & Degree

Andrzej Kurowski

First Name & Middle Initial & Last Name & Degree

Lukasz Czyżewski

12. IPD Sharing Statement

Learn more about this trial

Pediatric Intubation Among Nursing

We'll reach out to this number within 24 hrs