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

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Surgery

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: abdominal surgery; ∆POP: variation of the plethysmographic waveform of pulse oximetry; ∆PP: pulse pressure variation; pulse oximetry plethysmographic
• Other Study ID Numbers: D22215