CPAP and Lateral Neck Rotation on Anesthetized Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Children's Anesthesiology Associates, Ltd.
Information provided by:
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Hypoventilation Other: Continuous Positive Airway Pressure during MRI Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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. [ Time Frame: 10 minutes ]

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.). -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00592423

Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Principal Investigator: Ronald Litman, DO Children's Hospital of Philadelphia

Responsible Party: Ronald Litman, DO,, The Children's Hospital of Philadelphia Identifier: NCT00592423     History of Changes
Other Study ID Numbers: 2004-10-3977
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

Keywords provided by Children's Hospital of Philadelphia:
Lateral neck rotation
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms