Peripheral Perfusion Index in Weaning From Mechanical Ventilation

Completed

• Conditions: Weaning Failure

• Registration Number: NCT03974568
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-05
• Study Start: 2019-06-06
• Primary Completion: 2019-10-06
• Study Completion: 2019-10-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-25
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
peripheral perfusion index (PPI) ratio	30 minutes	PPI by the end of spontaneous breathing trial (SBT) / baseline PPI

Secondary Outcome Measures

Name	Time	Method
heart rate	30 minutes	beat per minutes
Rapid shallow breathing index	At end of 30 minutes of SBT	respiratory rate / tidal volume
peripheral perfusion index	30 minutes	ratio between pulsatile and non-pulsatile portions of peripheral circulation
respiratory rate	30 minutes	breath per minutes
systolic blood pressure	30 minutes	mmHg
cardiac output	30 minutes	litre/minutes
central venous pressure	30 minutes	cmH2O

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt