NCT02280213

Brief Summary

Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

October 28, 2014

Last Update Submit

January 31, 2015

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 day

Secondary Outcomes (5)

  • Success of intubation

    1 day

  • Ease of Use

    1 day

  • POGO score

    1 day

  • Cormack-Lehane grading

    1 day

  • dental compression

    1 day

Study Arms (2)

Intubation without chest compression

EXPERIMENTAL

Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.

Device: MILDevice: MACDevice: WISDevice: PHIL

Intubation with chest compression

EXPERIMENTAL

Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.

Device: MILDevice: MACDevice: WISDevice: PHIL

Interventions

MILDEVICE

Direct laryngoscopy 1

Also known as: Miller blade
Intubation with chest compressionIntubation without chest compression
MACDEVICE

Direct laryngoscopy 2

Also known as: Macintosh blade
Intubation with chest compressionIntubation without chest compression
WISDEVICE

Direct laryngoscopy 3

Also known as: Wis-Hipple blade
Intubation with chest compressionIntubation without chest compression
PHILDEVICE

Direct laryngoscopy 4

Also known as: Phillips blade
Intubation with chest compressionIntubation without chest compression

Eligibility Criteria

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

You may qualify if:

  • give voluntary consent to participate in the study
  • paramedics
  • no clinical experience in infant intubation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Institute of Rescue Research and Education

Warsaw, Masovia, 03-122, Poland

Location

Study Officials

  • Lukasz Szarpak

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 31, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations

PL(1)