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
About this trial
This is an interventional diagnostic trial for Hypoventilation focused on measuring Lateral neck rotation, Continuous Positive Airway Pressure
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.). -
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
NCT ID
NCT00592423
First Posted
January 2, 2008
Last Updated
September 14, 2009
Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Anesthesiology Associates, Ltd.
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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