Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
This trial is active, not recruiting.
|Sponsor||Hospices Civils de Lyon|
|Start date||October 2015|
|End date||April 2016|
|Trial size||20 participants|
|Trial identifier||NCT02817893, D22215|
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.
∆PP: pulse pressure variation
time frame: Day 0
∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry
time frame: Day 0
Male or female participants at least 18 years old.
- Hospital patient in general surgery and digestive department
- Digestive sus mesocolic surgery with direct abdominal approach justifying a semi-invasive hemodynamic monitoring by arterial catheterization (liver, pancreatic, gastric and duodenal surgery)
- Surgical approach by laparotomy
- Patient under general anesthesia with mechanical ventilation
- Agreeing to participate in the study after receiving information note
- Known left systolic ventricular and/or diastolic failure
- Surgery performed with thoracic approach
- Surgery by laparoscopy
- Emergency surgery
- Hypersensitivity or allergic to any of the product used for usual anesthesia, hypersensitivity to soya or egg lecithin
- Personal or familial history of malignant hyperthermia
- Severe kidney impairment (creatinin clearance <30ml/min)
- Patients who participated in the previous month to another study protocol
- Pregnant women or nursing
|Official title||Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)|
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