NCT00592423

Brief Summary

The primary aim of this study is to determine the changes in upper airway anatomy that occur during lateral neck rotation and subsequent administration of continuous positive airway pressure (CPAP) in anesthetized, spontaneously breathing children. The hypothesis for this study is that neck rotation decreases overall upper airway volume because of constriction at the level of the larynx, and that this constriction is relieved by administration of CPAP.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

4.6 years

First QC Date

January 2, 2008

Last Update Submit

September 14, 2009

Conditions

Hypoventilation

Keywords

Lateral neck rotationContinuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • This study will determine the anatomical mechanism for upper airway obstruction during lateral neck rotation and will elucidate the effects of administration of CPAP on this obstruction.

    10 minutes

Study Arms (1)

1

OTHER

A "convenience" sample of children will be utilized for this study, which will include both genders and all ethnicities. There is no known predilection for any racial or gender inequalities with regard to subject recruitment or outcome variables related to this study.

Other: Continuous Positive Airway Pressure during MRI

Interventions

Continuous Positive Airway Pressure during MRIOTHER

10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes.

1

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • MRI: Children requiring MRI examination with propofol sedation.
  • Bronchoscopy: Child requiring elective flexible bronchoscopy during general anesthesia. (1 child only) -

You may not qualify if:

  • Acute or chronic lung disease,
  • upper airway disease,
  • congestive heart failure,
  • obesity,
  • sleep apnea syndrome,
  • central nervous system disease likely to influence muscle tone,
  • any type of abnormality in head or neck anatomy, or
  • the requirement for any type of airway adjunct device (e.g., oral airway, endotracheal tube, etc.). -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald Litman, DO

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

January 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 16, 2009

Record last verified: 2009-09