NCT02277652

Brief Summary

The purpose of this study was to compare the four different intubation devices in 6 different scenarios.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1 month

First QC Date

October 26, 2014

Last Update Submit

November 11, 2014

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (4)

  • Success of intubation

    1 month

  • POGO score

    1 month

  • VAS score

    1 month

  • Cormack-Lehane grading

    1 month

Study Arms (6)

Scenario 1: Uninterrupted chest compressions

EXPERIMENTAL

Endotracheal intubation (ETI) during pediatric manikin with uninterrupted chest compressions. Chest compression was performed using LUCAS-2 (Physio-Control, USA).

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Scenario 2: Neutral position

EXPERIMENTAL

ETI performed in neutral mannikin head position

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Scenario 3: Sniffing position

EXPERIMENTAL

ETI performed in sniffing mannikin head position

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Scenario 4: Pharyngeal swelling

EXPERIMENTAL

ETI performed during mannikin pharyngeal swelling scenario

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Scenario 5: Swollen tongue

EXPERIMENTAL

ETI performed during mannikin swollen tongue scenario

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Scenario 6: Immobilized cervical spine

EXPERIMENTAL

ETI performed during mannikin immobilized cervical spine scenario

Device: The Miller LaryngoscopeDevice: The Bonfils intubation fibrescopeDevice: The GlideScope RangerDevice: The Supraglottic Airway Laryngopharyngeal Tube (SALT)

Interventions

The Miller LaryngoscopeDEVICE

Direct laryngoscopy

Scenario 1: Uninterrupted chest compressionsScenario 2: Neutral positionScenario 3: Sniffing positionScenario 4: Pharyngeal swellingScenario 5: Swollen tongueScenario 6: Immobilized cervical spine
The Bonfils intubation fibrescopeDEVICE

Optical laryngoscopy

Scenario 1: Uninterrupted chest compressionsScenario 2: Neutral positionScenario 3: Sniffing positionScenario 4: Pharyngeal swellingScenario 5: Swollen tongueScenario 6: Immobilized cervical spine
The GlideScope RangerDEVICE

Videolaryngoscopy

Scenario 1: Uninterrupted chest compressionsScenario 2: Neutral positionScenario 3: Sniffing positionScenario 4: Pharyngeal swellingScenario 5: Swollen tongueScenario 6: Immobilized cervical spine
The Supraglottic Airway Laryngopharyngeal Tube (SALT)DEVICE

Blind intubation

Scenario 1: Uninterrupted chest compressionsScenario 2: Neutral positionScenario 3: Sniffing positionScenario 4: Pharyngeal swellingScenario 5: Swollen tongueScenario 6: Immobilized cervical spine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • give voluntary consent to participate in the study
  • minimum 1 year of work experience in emergency medicine
  • experienced emergency medical personnel (paramedics, nurses, physicians)

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

RECRUITING

Study Officials

  • Lukasz Szarpak

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

  • Andrzej Kurowski

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukasz Szarpak

CONTACT

(+48)500186225lukasz.szarpak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 26, 2014

First Posted

October 29, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

PL(1)