- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974568
Peripheral Perfusion Index in Weaning From Mechanical Ventilation
Evaluation of Peripheral Perfusion Index as a Predictor of Failure of Weaning From Mechanical Ventilation
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- mechanically ventilated patients for more than 48 hours
Exclusion Criteria:
- patients < 18 years
- patients with peripheral vascular disease
- patients on vasopressors
- patients with hand injuries hindering which would preclude the application of the device probe
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 |
---|---|---|
peripheral perfusion index (PPI) ratio
Time Frame: 30 minutes
|
PPI by the end of spontaneous breathing trial (SBT) / baseline PPI
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peripheral perfusion index
Time Frame: 30 minutes
|
ratio between pulsatile and non-pulsatile portions of peripheral circulation
|
30 minutes
|
heart rate
Time Frame: 30 minutes
|
beat per minutes
|
30 minutes
|
systolic blood pressure
Time Frame: 30 minutes
|
mmHg
|
30 minutes
|
cardiac output
Time Frame: 30 minutes
|
litre/minutes
|
30 minutes
|
central venous pressure
Time Frame: 30 minutes
|
cmH2O
|
30 minutes
|
respiratory rate
Time Frame: 30 minutes
|
breath per minutes
|
30 minutes
|
Rapid shallow breathing index
Time Frame: At end of 30 minutes of SBT
|
respiratory rate / tidal volume
|
At end of 30 minutes of SBT
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N-159-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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