Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude
|ClinicalTrials.gov Identifier: NCT02852473|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : October 14, 2016
This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.
The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Continuous Positive Airway Pressure||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.
Other: Continuous Positive Airway Pressure
CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.
- Change in Breathing Motion Characteristics at High CPAP Setting [ Time Frame: Data acquisition for this portion of the study will require approximately 30 minutes. ]Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).
- Change in Breathing Motion Characteristics at Lower CPAP Setting [ Time Frame: Approximately 45 minutes into visit. ]Time permitting, the CPAP setting will be reduced to approximately half of the nominal/tolerable/high CPAP setting. Using the same MRI sequences and retrospective sorting technique, 4D-MRI will be generated for this lower CPAP setting. Analogous motion characterization analyses (to outcome measure 1) will be carried out for the lower CPAP setting (relative to baseline 4D-MRI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852473
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Erik J Tryggestad, PhD||Mayo Clinic|