An observational study in Perfusion; Complications and Mechanical Ventilation Complication, sponsored by St. Bortolo Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by St. Bortolo Hospital · Observational
The present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Renal perfusion will be assessed at baseline (PEEP 0), subsequently ,at the application of progressive increases of PEEP. At the end of the measurements, the implications of the use of PEEP on the renal vascular system will be analyzed.
The present physiological, monocentric, observational clinical study evaluates the effect of progressive PEEP increases on renal perfusion in mechanically ventilated patients who underwent surgery with the need of ventilatory support and monitoring in intensive care.
Precisely, will be evaluated:
The intra-class correlation coefficient will be measured to estimate the intra-observer reproducibility of the conducted measurement.
St. Bortolo Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing surgery and with the need for ventilatory support for the intensive care unit
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Enrolled patients will receive a sequential, step-wise increase in PEEP from 0 cmH2O to 12 cmH2O. The inter-lobar arterioles will be sampled at each PEEP increment and the IR will be measured as the average of three values recorded at the upper and lower pole and at the mesorenes in each kidney. Gas exchanges, HR, systolic, diastolic and mean PA, Pmax, P1 and P2 airway, total resistance and ohmic resistance and static respiratory compliance indexed for body weight (RRSmaxI, RRSminI, CrsI) will be measured at each Peep Level. The physiologic measurements will be obtained at regular intervals (within 15 minutes at each PEEP level) throughout the PEEP titration period.
Association between IR and PEEP
Resistive index will be measured in both kidney and recorded using multifrequency convex probe.The association between positive end expiratory pressure and resistive index will be analyzed as the primary outcome.
Time frame: Change from baseline to 60 minutes
Association between PEEP and Hemodynamics Paramenters
Resistive index will be measured in both kidney and recorded using multifrequency convex. FC, systolic, diastolic and mean PA will be measured at each PEEP level
Time frame: Change from baseline to 60 minutes
Association between IR and Respiratory exchanges
Resistive index will be measured in both kidney and recorded using multifrequency convex. PaO2 and PaCO2 will be analyzed at each PEEP level.
Time frame: Change from baseline to 60 minutes
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2018 (actual). Primary completion is estimated for May 2019, 6 months after the start.
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This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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St. Bortolo Hospital