CPAP and Lateral Neck Rotation on Anesthetized Children
|ClinicalTrials.gov Identifier: NCT00592423|
Recruitment Status : Terminated (Preliminary data was inconclusive to warrant keeping the study open.)
First Posted : January 14, 2008
Last Update Posted : September 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hypoventilation||Other: Continuous Positive Airway Pressure during MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Neck Rotation and Continuous Positive Airway Pressure (CPAP) on Upper Airway Anatomy in Anesthetized Children - an MRI Study|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
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
10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592423
|Principal Investigator:||Ronald Litman, DO||Children's Hospital of Philadelphia|