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

Abdominal Surgery Clinical Trial

— PLETHYSMO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02817893
• Other study ID #: D22215
• Status: Active, not recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: June 28, 2016
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?PP: pulse pressure variation	reference index measured during abdominal surgery	Day 0	No
Primary	?POP: respiratory variation of the plethysmographic waveform of pulse oximetry	noninvasive index obtained from plethysmographic raw signal measured during abdominal surgery	Day 0	No