Abdominal SurgeryPLETHYSMONCT02817893
Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
An observational study of Abdominal Surgery, run by Hospices Civils de Lyon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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.
- Conditions
- Abdominal Surgery
- Keywords
- ∆POP: variation of the plethysmographic waveform of pulse oximetry, ∆PP: pulse pressure variation, pulse oximetry plethysmographic, abdominal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
∆PP: pulse pressure variation
reference index measured during abdominal surgery
Measured: Day 0
∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry
noninvasive index obtained from plethysmographic raw signal measured during abdominal surgery
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817893
- Sponsor's protocol ID
- D22215
- Acronym
- PLETHYSMO
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)
- ClinicalTrials.gov ID
- NCT02817893
- Acronym / sponsor ID
- PLETHYSMO / D22215
- Conditions
- Abdominal Surgery
- Keywords
- ∆POP: variation of the plethysmographic waveform of pulse oximetry, ∆PP: pulse pressure variation, pulse oximetry plethysmographic, abdominal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Known left systolic ventricular and/or diastolic failure
- Arrhythmias
- Surgery performed with thoracic approach
- Surgery by laparoscopy
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
∆PP: pulse pressure variation
Time frame: Day 0
reference index measured during abdominal surgery
∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry
Time frame: Day 0
noninvasive index obtained from plethysmographic raw signal measured during abdominal surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
∆PP: pulse pressure variation (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.