An observational study in Weaning Failure, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Cairo University · Observational
Peripheral perfusion index (PPI) is variable measured by Radical-7 (Masimo) device and reflects the ratio between pulsatile and non-pulsatile portions of peripheral circulation. PPI is characterized by being non-invasive, real time, and simple variable. Impairment of various perfusion indices (such as central venous oxygen saturation and serum lactate) during spontaneous breathing trial (SBT) were previously reported; however, these indices are characterized by being relatively invasive. We hypothesized that impairment of PPI during SBT might be predictive of weaning failure. The aim of this work was to evaluate the possible association between PPI and success of SBT
This prospective observational study will be carried out in surgical intensive care unit (SICU) unit of trauma and emergency hospital at Cairo University teaching hospital. Informed consent will be obtained from patients' next-of-kin prior to the enrolment in the study. All mechanically ventilated patients for more than 48 hours presented will be consecutively included.
The excluded patients are: patients \< 18 years, patients with peripheral vascular disease, patients on vasopressors, and those with hand injuries hindering which would preclude the application of the device probe will be excluded.
Assessment of readiness to wean from mechanical ventilation will be done by ICU physician according to the ICU protocol Spontaneous breathing trial (SBT) will be applied through pressure support (PS) mode with PS 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O for 30 minutes; then, weaning parameters will be assessed again. The decision of extubation will be taken by the intensivist in charge who is blinded to peripheral perfusion index (PPI) measurements. Weaning failure will be defined according to the guidelines of international conference on weaning from mechanical ventilation PPI will be continuously monitored using Radical-7 device pulse co-oximeter (Masimo corporation, Irvine, CA) via a pulse oximeter probe applied to the third or fourth digit of left hand. The probe will be covered with an opaque shield to avoid any error by external light sources. A baseline reading for PPI will be obtained followed by a reading each 5 minutes till the end of the SBT. We calculated a PPI ratio to evaluate the change in PPI during SBT. PPI ratio is defined as PPI by the end of SBT / baseline PPI).
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
mechanically ventilated patients for more than 48 hours
Exclusion Criteria:
peripheral perfusion index (PPI) ratio
PPI by the end of spontaneous breathing trial (SBT) / baseline PPI
Time frame: 30 minutes
peripheral perfusion index
ratio between pulsatile and non-pulsatile portions of peripheral circulation
Time frame: 30 minutes
heart rate
beat per minutes
Time frame: 30 minutes
systolic blood pressure
mmHg
Time frame: 30 minutes
cardiac output
litre/minutes
Time frame: 30 minutes
central venous pressure
cmH2O
Time frame: 30 minutes
respiratory rate
breath per minutes
Time frame: 30 minutes
Rapid shallow breathing index
respiratory rate / tidal volume
Time frame: At end of 30 minutes of SBT
Plan to share: Undecided
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Cairo University