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

• Conditions: Abdominal Surgery

• Registration Number: NCT02817893
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
∆PP: pulse pressure variation	Day 0	reference index measured during abdominal surgery
∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry	Day 0	noninvasive index obtained from plethysmographic raw signal measured during abdominal surgery