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Completed

NCT Number: NCT03974568

Peripheral Perfusion Index in Weaning From Mechanical Ventilation

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

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Key information

Conditions

Weaning Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. peripheral perfusion index (PPI) ratio

    Time frame: 30 minutes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Peripheral Perfusion Index as a Predictor of Failure of Weaning From Mechanical Ventilation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2019
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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