Clinical trial NCT02817893: Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
Official title: Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Surgery
Keywords: ∆POP: variation of the plethysmographic waveform of pulse oximetry
∆PP: pulse pressure variation
pulse oximetry plethysmographic
abdominal surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo sus mesocolic surgery under general anesthesia and by direct approach, whose anesthesic management requires continuous monitoring of blood pressure (arterial catheter).

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.


Eligibility criteria: Inclusion Criteria:

* Hospital patient in general surgery and digestive department
* Adult
* 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

Exclusion Criteria:

* Known left systolic ventricular and/or diastolic failure
* Arrhythmias
* 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
* Under-age

Primary outcomes:
measure: ∆PP: pulse pressure variation
timeFrame: Day 0
measure: ∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: