An interventional study of Chest wall movement assessment without CPAP and Breath hold assessment without CPAP in Healthy Volunteers and Effect of CPAP on Chest Movement, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Health services research
CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing and chest wall motion.
CPAP is a non-invasive ventilation technique that is commonly used to treat sleep apnea. Using a small air-pump, tubing and facemask, it provides a constant stream of pressurized air to the upper airways and lungs. Some of the physiological effects noted during CPAP are hyperinflation of the lungs, stabilizing and flattening of the diaphragm, and decrease in tidal volume. The effects on duration of breath hold are unknown. During radiation treatment, these effects are expected to reduce tumor and organ motion which reduces the volume of normal tissue being irradiated and also creates favorable treatment geometry by moving the heart away from the anterior chest wall. An important advantage of CPAP compared to other techniques is that active patient cooperation is not required. The potential exists to combine use of CPAP with other respiratory management techniques such as breath hold and improve overall effectiveness. When used in sleep apnea it is well tolerated and poses little risk to patients. There are no published reports of the use of CPAP in radiation therapy.
In initial studies the Varian RPM system was used to assess respiratory motion with and without CPAP for patients receiving radiation therapy. This commercially available, non-invasive system works by directing an infrared beam onto an infrared motion detector that is placed on the patients' upper abdomen. The detector records the change in abdomen position that occurs with respiration as a change in amplitude of the detector position. Interventions that effect respiration will be recorded by an increase or decrease in the amplitude of the detector motion. When used in breath hold, the detector remains in a fixed position with a very narrow gating window.
Based on initial experience with the RPM system, it has been found that approximately 1 hour of CPAP use is required to reduce diaphragm motion. Although early results are favorable using this approach, it is not certain that this is the best or most efficient method of use for all patients. The use of CPAP combined with breath hold techniques has not been studied.
The objectives of this study are to use the RPM system in normal volunteers to:
Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
No contraindications to the use of CPAP
Exclusion Criteria:
Contraindications to CPAP
this is a single arm study. All subjects treated the same way, and undergo four interventions: 1. Chest wall movement assessment without CPAP 2. Breath hold assessment without CPAP 3. Chest wall movement assessment with CPAP 4. Breath hold assessment with CPAP
Behavioral: Chest wall movement assessment without CPAP · Behavioral: Breath hold assessment without CPAP · Procedure: Chest wall movement assessment with CPAP · Procedure: Breath hold assessment with CPAP
While subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
While subject is breathing normally, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
While subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
While subject is breathing via CPAP machine, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
Chest wall motion amplitude
Amplitude of chest wall motion, measured in centimeters.
Time frame: 2 hours
Duration of breath hold
Length (in seconds) that are subjects able to hold their breath.
Time frame: 2 hours
Reproducibility of breath hold depth
When 'breath hold' is performed three consecutive times, ascertain if it performed to the same depth each time. Measured in centimeters.
Time frame: 2 hours
Respiratory rate
Number of breaths per minute.
Time frame: 2 hours
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheba Medical Center