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Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)

Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02817893
Acronym
PLETHYSMO
Enrollment
20
Registered
2016-06-29
Start date
2015-10-31
Completion date
2016-08-31
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery

Keywords

∆POP: variation of the plethysmographic waveform of pulse oximetry, ∆PP: pulse pressure variation, pulse oximetry plethysmographic, abdominal surgery

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.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
∆PP: pulse pressure variationDay 0reference index measured during abdominal surgery
∆POP: respiratory variation of the plethysmographic waveform of pulse oximetryDay 0noninvasive index obtained from plethysmographic raw signal measured during abdominal surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026