Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT02817893
Status:
UNKNOWN
Last Update Posted:
2016-06-29
First Post:
2016-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PLETHYSMO
Brief Summary:
The waveform plethysmographic signal can be used to establish an index for predicting fluid responsiveness (∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry). This index was validated in some studies and because of its non-invasiveness it seems very interesting in anesthesia.
However, in a previous study the investigators evaluated the correlation between the results provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure variation), and the obtained results were significantly lower than what had been previously described. In this study, the index was calculated from a recording of a filtered signal. This unavoidable application of a filter on anesthesia monitors could contribute to the discrepancy between the ∆POP and the ∆PP.
The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.
However, in a previous study the investigators evaluated the correlation between the results provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure variation), and the obtained results were significantly lower than what had been previously described. In this study, the index was calculated from a recording of a filtered signal. This unavoidable application of a filter on anesthesia monitors could contribute to the discrepancy between the ∆POP and the ∆PP.
The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: