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CompletedNCT03974568Updated Jan 28, 2020

Peripheral Perfusion Index in Weaning From Mechanical Ventilation

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
18 Years and older
Sex
All
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Study 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

Read the 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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Conditions studied

  • Weaning Failure
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

mechanically ventilated patients for more than 48 hours

Inclusion criteria

  • mechanically ventilated patients for more than 48 hours

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. peripheral perfusion index (PPI) ratio

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

    Time frame: 30 minutes

Secondary outcomes

  1. peripheral perfusion index

    ratio between pulsatile and non-pulsatile portions of peripheral circulation

    Time frame: 30 minutes

  2. heart rate

    beat per minutes

    Time frame: 30 minutes

  3. systolic blood pressure

    mmHg

    Time frame: 30 minutes

  4. cardiac output

    litre/minutes

    Time frame: 30 minutes

  5. central venous pressure

    cmH2O

    Time frame: 30 minutes

  6. respiratory rate

    breath per minutes

    Time frame: 30 minutes

  7. Rapid shallow breathing index

    respiratory rate / tidal volume

    Time frame: At end of 30 minutes of SBT

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Study locations

1 site
  • Cairo University
    Cairo, Egypt
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References and documents

Publications

  • Lotfy A, Hasanin A, Rashad M, Mostafa M, Saad D, Mahmoud M, Hamimy W, Fouad AZ. Peripheral perfusion index as a predictor of failed weaning from mechanical ventilation. J Clin Monit Comput. 2021 Apr;35(2):405-412. doi: 10.1007/s10877-020-00483-1. Epub 2020 Feb 8. PubMed 32036499 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03974568
Lead sponsor
Cairo University
Responsible party
Ahmed Hasanin (assistant professor, Cairo University) — Principal investigator
First posted
Jun 5, 2019
Start date
Jun 6, 2019
Primary completion
Oct 6, 2019
Completion
Oct 10, 2019
Last update
Jan 28, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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