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Peripheral Perfusion Index in Weaning From Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT03974568
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, 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

Condition or disease
Weaning Failure

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).


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Study Type : Observational
Estimated Enrollment : 42 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 : June 6, 2019
Estimated Primary Completion Date : October 6, 2019
Estimated Study Completion Date : October 10, 2019



Primary Outcome Measures :
  1. peripheral perfusion index (PPI) ratio [ Time Frame: 30 minutes ]
    PPI by the end of spontaneous breathing trial (SBT) / baseline PPI


Secondary Outcome Measures :
  1. peripheral perfusion index [ Time Frame: 30 minutes ]
    ratio between pulsatile and non-pulsatile portions of peripheral circulation

  2. heart rate [ Time Frame: 30 minutes ]
    beat per minutes

  3. systolic blood pressure [ Time Frame: 30 minutes ]
    mmHg

  4. cardiac output [ Time Frame: 30 minutes ]
    litre/minutes

  5. central venous pressure [ Time Frame: 30 minutes ]
    cmH2O

  6. respiratory rate [ Time Frame: 30 minutes ]
    breath per minutes

  7. Rapid shallow breathing index [ Time Frame: At end of 30 minutes of SBT ]
    respiratory rate / tidal volume


Biospecimen Retention:   Samples Without DNA
arterial blood gases (ABG)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mechanically ventilated patients for more than 48 hours
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974568


Contacts
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Contact: Cairo university research ethics committee 01003657120 ext +2 kasralainirec@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: ahmed Hasanin, Lecturer    +2010095076954    ahmedmohamedhasanin@gmail.com   
Sponsors and Collaborators
Cairo University

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Responsible Party: Ahmed Hasanin, assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03974568     History of Changes
Other Study ID Numbers: N-159-2018
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No