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CPAP and Lateral Neck Rotation on Anesthetized Children

Primary Purpose

Hypoventilation

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure during MRI
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoventilation focused on measuring Lateral neck rotation, Continuous Positive Airway Pressure

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 2, 2008
    Last Updated
    September 14, 2009
    Sponsor
    Children's Hospital of Philadelphia
    Collaborators
    Children's Anesthesiology Associates, Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00592423
    Brief Title
    CPAP and Lateral Neck Rotation on Anesthetized Children
    Official Title
    Effect of Neck Rotation and Continuous Positive Airway Pressure (CPAP) on Upper Airway Anatomy in Anesthetized Children - an MRI Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Preliminary data was inconclusive to warrant keeping the study open.
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Hospital of Philadelphia
    Collaborators
    Children's Anesthesiology Associates, Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The most commonly performed surgical procedure requiring general anesthesia in the pediatric population is myringotomy and placement of pressure equalizing tubes in the middle ear. It is performed in otherwise healthy children with chronic middle ear fluid collections and infections. In these cases, general anesthesia is accomplished by inhalation of a volatile anesthetic gas, which induces unconsciousness and analgesia for the approximately 10 minutes it takes to perform the procedure. A requirement of the procedure is lateral neck rotation by the anesthesiologist managing the airway. This enhances surgical visibility (Fig 1). However, a well-known clinical consequence of lateral neck rotation is development of upper airway obstruction with subsequent hypoxemia.1 Anesthesiologists routinely counteract this problem by placement of an oral airway device or application of CPAP, or both. Nevertheless, intervening hypoxia often necessitates temporary halting of the procedure and resumption of the neutral neck position until hypoxemia abates. 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. This study will use an MRI imaging technique that has been used recently at CHOP by Drs. Raanan Arens and Soroosh Mahboubi to study the three-dimensional characteristics of the upper airway in children. This methodology, which was developed at the University of Pennsylvania and CHOP, utilizes fuzzy connectedness-based automatic segmentation that allows visualization of the upper airway in a correct anatomical orientation as it relates to airflow.2,3 This technology has been successfully applied to anesthetized children without any apparent adverse effects (see IRB # 2003-2-3189). An additional evaluable patient will be photographed during elective bronchoscopy with general anesthesia to correlate the MRI images with images visualized clinically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoventilation
    Keywords
    Lateral neck rotation, Continuous Positive Airway Pressure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Continuous Positive Airway Pressure during MRI
    Intervention Description
    10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes.
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: MRI: Children requiring MRI examination with propofol sedation. Bronchoscopy: Child requiring elective flexible bronchoscopy during general anesthesia. (1 child only) - Exclusion Criteria: 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.). -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Litman, DO
    Organizational Affiliation
    Children's Hospital of Philadelphia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    CPAP and Lateral Neck Rotation on Anesthetized Children

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