Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059137
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-04-18
Brief Title:
Breathing Cycle Biofeedback During Computed Tomography Procedures
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Respiratory Cycle Biofeedback During CT Guided Procedures
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of a flexible belt device in guiding patient breathing during computed tomography CT-guided needle biopsy When patients undergo CT scanning to help guide the physician during a tissue biopsy they are usually asked to hold their breath while the scan is taken of certain parts of the body When the first scan is completed the patients are allowed to breathe and are then asked to hold their breath again while the needle is advanced towards the tissue to be biopsied Since body organs and tissues move with breathing this study will try to stop the patients breathing at the same place in the breathing cycle to ensure that the biopsy target stays still and in the same place This study will see if the flexible belt used with a computer screen that charts the patients breathing will improve the patients ability to stop breathing at the same place in the breathing cycle before and during the biopsy
Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest or abdominal area may be eligible for this study The biopsy procedure must require CT scan guidance
Participants will undergo the following procedures
Breathing exercise A flexible loose-fitting belt is placed around the patients abdomen and the patient is asked to stop breathing in the following ways 1 take a deep breath in and hold 2 breathe deeply out and hold and 3 breathe regularly and hold
Needle biopsy The patient is positioned in a CT scanner and is asked to hold his or her breath while an initial scan is taken Then the patient is taken out of the scanner and the place the needle entry site for the biopsy is marked on the skin A local anesthetic is applied to the site and the patient is asked to hold his or her breath the same way as before During this breath hold the patient may or may not be shown a computer screen displaying a graph of the patients breathing and the point in the cycle of the previous breath hold The biopsy is then performed with CT guidance While the CT pictures are being taken the patient is again asked to breathe and hold his or her breath as before When the biopsy is completed the belt device is removed
Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest or abdominal area may be eligible for this study The biopsy procedure must require CT scan guidance
Participants will undergo the following procedures
Breathing exercise A flexible loose-fitting belt is placed around the patients abdomen and the patient is asked to stop breathing in the following ways 1 take a deep breath in and hold 2 breathe deeply out and hold and 3 breathe regularly and hold
Needle biopsy The patient is positioned in a CT scanner and is asked to hold his or her breath while an initial scan is taken Then the patient is taken out of the scanner and the place the needle entry site for the biopsy is marked on the skin A local anesthetic is applied to the site and the patient is asked to hold his or her breath the same way as before During this breath hold the patient may or may not be shown a computer screen displaying a graph of the patients breathing and the point in the cycle of the previous breath hold The biopsy is then performed with CT guidance While the CT pictures are being taken the patient is again asked to breathe and hold his or her breath as before When the biopsy is completed the belt device is removed
Detailed Description:
This study will examine the use of a flexible belt placed across the patients abdomen to sense and plot the patients respiratory cycle The point in the respiratory cycle at which the patient holds hisher breath will be recorded at different levels and correlated with CT scans and prior patient breathing levels Our hypothesis is that a graphical representation of the respiratory cycle may make it easier for the patient to hold his or her breath at the same level each time a CT scan is obtained or a needle is inserted If this is true then this should translate into faster safer procedures with potentially less ionizing radiation although this endpoint is not defined in this particular study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CC-0166 | None | None | None |