Effect of CPAP on Breath Hold and Chest Movement in Normal Volunteers

NCT ID: NCT02545686

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-09-30

Brief Summary

CPAP will be applied to normal volunteers inorder to understand CPAP's effects on breathing and chest wall motion.

Detailed Description

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:

1. Study the effects of CPAP on diaphragm motion to allow better optimization for the use of CPAP as a respiratory management technique during free breathing.

2. Determine the feasibility of use of CPAP as a respiratory aid for use in patients treated with breath hold techniques. Determine the effects of CPAP on duration; reproducibility and tolerance of the breath hold technique.

Conditions

Healthy Volunteers; Effect of CPAP on Chest Movement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

one

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

Group Type: EXPERIMENTAL

Chest wall movement assessment without CPAP

Intervention Type: BEHAVIORAL

While subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.

Breath hold assessment without CPAP

Intervention Type: BEHAVIORAL

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.

Chest wall movement assessment with CPAP

Intervention Type: PROCEDURE

While subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.

Breath hold assessment with CPAP

Intervention Type: PROCEDURE

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.

Interventions

Chest wall movement assessment without CPAP

While subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.

Intervention Type: BEHAVIORAL

Breath hold assessment without CPAP

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.

Intervention Type: BEHAVIORAL

Chest wall movement assessment with CPAP

While subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.

Intervention Type: PROCEDURE

Breath hold assessment with CPAP

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Normal volunteers without a cancer diagnosis.
• No contraindications to the use of CPAP

• Facial injury or deformity preventing wearing facial mask
• Recurrent vomiting
• Chronic cough with phlegm
• Previous pneumothorax
• Facial lacerations or fractures
• Recent tracheal or esophageal anastomosis
• Recent GI surgery (last 90 days).
• 18-90 years of age
• Ability to sign informed consent
• Hebrew or English speakers

Exclusion Criteria

• Contraindications to CPAP

• Facial injury or deformity preventing wearing facial mask
• Recurrent vomiting
• Chronic cough with phlegm
• Previous pneumothorax
• Facial lacerations or fractures
• Recent tracheal or esophageal anastomosis
• Recent GI surgery (last 90 days).
• Under age 18 or above age 90 years
• Inability to sign informed consent
• Members of special populations (mental illness, pregnant women, prisoners, not legally competent).
• History of severe active restrictive or obstructive lung disease (as defined as at least one hospitalization over previous two years)
• Any medical condition requiring an inpatient hospitalization for more than 72 hours over the previous 2 years, aside from elective surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hila Gnessin

Role: CONTACT

Phone: 972-3-5307340

Email: Hila.Gnessin@sheba.health.gov.il

Eve Keret

Role: CONTACT

Phone: 972-3-5303207

Email: Eve.Keret@sheba.health.gov.il

Facility Contacts

Yaacov R Lawrence, MBBS MA MRCP

Role: primary

Hila Gnessin

Role: backup

Other Identifiers

SHEBA-15-2364-YL-CTIL

Identifier Type: -

Identifier Source: org_study_id