NCT00532636

Brief Summary

Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. The head of children is randomly placed in different head positions by one investigator. A ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. This information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

First QC Date

September 18, 2007

Last Update Submit

March 25, 2009

Conditions

Healthy

Keywords

AirwayAirway obstructionMouth-to-mask resuscitationRespiration artificialVentilationVentilation of an unprotected airwaySafety and efficiency of mask ventilationAvoidance of stomach inflation

Study Arms (2)

1

ACTIVE COMPARATOR

Children 1-5 years of age

Procedure: Ventilation

2

ACTIVE COMPARATOR

Children 6-10 years of age

Procedure: Ventilation

Interventions

VentilationPROCEDURE

Mask ventilation in neutral and head extension position

1

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II children, 1-10 years of age

You may not qualify if:

  • Facial deformity
  • Pathological airway or cervical spine
  • BMI\>35
  • History of gastric reflux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Related Publications (1)

  • Paal P, Niederklapfer T, Keller C, von Goedecke A, Luckner G, Pehboeck D, Mitterlechner T, Herff H, Riccabona U, Wenzel V. Head-position angles in children for opening the upper airway. Resuscitation. 2010 Jun;81(6):676-8. doi: 10.1016/j.resuscitation.2010.01.022. Epub 2010 Mar 26.

    PMID: 20346568DERIVED

MeSH Terms

Conditions

Airway ObstructionRespiratory Aspiration

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Volker Wenzel, Prof., MD, MSc

    Dept. of Anesthesia and Critical Care Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 20, 2007

Study Start

January 1, 2006

Study Completion

December 1, 2006

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

AU(1)