HypoventilationNCT00592423
CPAP and Lateral Neck Rotation on Anesthetized Children
A study testing Continuous Positive Airway Pressure during MRI in people with Hypoventilation, run by Children's Hospital of Philadelphia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Hypoventilation
- What is being tested?
- Continuous Positive Airway Pressure during MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- MRI: Children requiring MRI examination with propofol sedation.
- Bronchoscopy: Child requiring elective flexible bronchoscopy during general anesthesia. (1 child only) -
Who cannot join
- 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.). -
About this study
Official title: Effect of Neck Rotation and Continuous Positive Airway Pressure (CPAP) on Upper Airway Anatomy in Anesthetized Children - an MRI Study
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.
Read the 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.
- Conditions
- Hypoventilation
- Being tested
- Continuous Positive Airway Pressure during MRI
- Keywords
- Lateral neck rotation, Continuous Positive Airway Pressure
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Continuous Positive Airway Pressure during MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Preliminary data was inconclusive to warrant keeping the study open.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Investigators
- Ronald Litman, DO, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592423
- Sponsor's protocol ID
- 2004-10-3977
- Status last verified
- Sep 2009
- First submitted
- 2 Jan 2008
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neck Rotation and Continuous Positive Airway Pressure (CPAP) on Upper Airway Anatomy in Anesthetized Children - an MRI Study
- ClinicalTrials.gov ID
- NCT00592423
- Acronym / sponsor ID
- 2004-10-3977
- Conditions
- Hypoventilation
- Keywords
- Lateral neck rotation, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary data was inconclusive to warrant keeping the study open.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Children's Anesthesiology Associates, Ltd.
- Study start
- Jan 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Continuous Positive Airway Pressure during MRIA "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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- MRI: Children requiring MRI examination with propofol sedation.
- Bronchoscopy: Child requiring elective flexible bronchoscopy during general anesthesia. (1 child only) -
Key exclusion criteria (8 listed)
- Acute or chronic lung disease,
- upper airway disease,
- congestive heart failure,
- obesity,
- sleep apnea syndrome,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure during MRI10 cm H20 pressure for CPAP while lateral neck positioning is done for MRI - each side should take 5 minutes. | Other | 1 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Preliminary data was inconclusive to warrant keeping the study open.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Litman, DO principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure during MRI in people with Hypoventilation, run by Children's Hospital of Philadelphia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Preliminary data was inconclusive to warrant keeping the study open.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2009.