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Peripheral Perfusion Index in Weaning From Mechanical Ventilation

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03974568
Collaborator
(none)
43
Enrollment
1
Location
4.1
Actual Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Peripheral Perfusion Index as a Predictor of Failure of Weaning From Mechanical Ventilation
    Actual Study Start Date :
    Jun 6, 2019
    Actual Primary Completion Date :
    Oct 6, 2019
    Actual Study Completion Date :
    Oct 10, 2019

    Outcome Measures

    Primary Outcome Measures

    1. peripheral perfusion index (PPI) ratio [30 minutes]

      PPI by the end of spontaneous breathing trial (SBT) / baseline PPI

    Secondary Outcome Measures

    1. peripheral perfusion index [30 minutes]

      ratio between pulsatile and non-pulsatile portions of peripheral circulation

    2. heart rate [30 minutes]

      beat per minutes

    3. systolic blood pressure [30 minutes]

      mmHg

    4. cardiac output [30 minutes]

      litre/minutes

    5. central venous pressure [30 minutes]

      cmH2O

    6. respiratory rate [30 minutes]

      breath per minutes

    7. Rapid shallow breathing index [At end of 30 minutes of SBT]

      respiratory rate / tidal volume

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Hasanin, assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03974568
    Other Study ID Numbers:
    • N-159-2018
    First Posted:
    Jun 5, 2019
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 28, 2020