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Recruiting NCT07120672

PPI in Weaning Prediction

Observational Perfusion Index Weaning of Mechanical Ventilation ICU

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patients were monitored for reentubation for 48 hours., weaning group.
Who it may be relevant to
Registry conditions: Perfusion Index, Weaning of Mechanical Ventilation, ICU. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Role of Peripheral Perfusion Index as a Predictive Factor During Weaning Process

Overview

The aim of this study is to evaluate the predictive role of the Peripheral Perfusion Index (PPI) in forecasting extubation success during the weaning process in intensive care unit (ICU) patients. The study will investigate the ability of PPI to predict extubation failure by comparing it with traditional weaning criteria, including the Rapid Shallow Breathing Index (RSBI), PaO₂/FiO₂ ratio, and respiratory rate.

Detailed description

Study Protocol This prospective observational study will be conducted in the Anesthesia Intensive Care Unit of Istanbul Gaziosmanpaşa Training and Research Hospital (SUAM) between March 2025 and June 2025 following approval from the Ethics Committee. Written informed consent will be obtained from the patients' legal representatives prior to enrollment.

Readiness for weaning from mechanical ventilation will be evaluated by the same attending intensivist throughout the study, in accordance with the local protocol. Criteria for readiness include resolution of the underlying cause of mechanical ventilation, ability to tolerate temporary discontinuation of mechanical ventilation, absence of frequent endotracheal suctioning needs, adequate oxygenation (PaO₂ \> 60 mmHg with FiO₂ ≤ 0.5 and PEEP ≤ 8 cmH₂O), acceptable pH and PaCO₂ based on the patient's baseline respiratory condition, and stable cardiovascular status. In patients at high risk for upper airway edema, a cuff leak test will be performed by the intensivist.

The spontaneous breathing trial (SBT) will be performed using the Pressure Support (PS) mode with 5 cmH₂O PS and 5 cmH₂O PEEP. After 30 minutes, weaning parameters will be reassessed and the intensivist will make the extubation decision.

SBT failure will be defined by the presence of one or more of the following criteria: altered mental status, respiratory rate \> 35 breaths/min, RSBI \> 105, signs of increased respiratory effort (use of accessory muscles, thoracoabdominal asynchrony, intercostal retractions), SpO₂ \< 90% or PaO₂ \< 60 mmHg on FiO₂ of 0.4, or hemodynamic instability (heart rate \> 140 bpm, systolic blood pressure \> 180 mmHg or \< 90 mmHg, or a change in either \> 20% from baseline).

Patients with successful SBT will be extubated and monitored for 48 hours for the need for reintubation. Supplemental oxygen will be provided via a simple oxygen mask (4-6 L/min) to maintain SpO₂ \> 92%.

The primary outcome is the ability of the Peripheral Perfusion Index (PPI) measured 1 hour after extubation to predict extubation failure within 48 hours.

The secondary outcomes include the predictive ability of PPI measured at the beginning of SBT, at 15 minutes, at the end of SBT, and 2 hours after extubation in identifying patients who will require reintubation within 48 hours.

Interventions

  • Other patients were monitored for reentubation for 48 hours.
    patients were monitored for reentubation for 48 hours.
  • Other weaning group
    patients were monitored for reentubation for 48 hours.

Primary outcome measures

  • • The ability of Peripheric Perfusion Index(PPI) measured 1 hour after extubation to predict extubation failure within 48 hours following extubation. [Time frame: 48 hours]
Secondary outcome measures (3)
  • • The predictive power of Peripheric Perfusion Index(PPI) measured at the beginning of the spontaneous breathing trial (SBT), at the 15th minute, at the end of SBT, and 2 hours after extubation in determining extubation success. [Time frame: 3 hours]
  • • Correlation of Peripheric Perfusion Index(PPI) measurements between cardiac patients(Patients with at least one diagnosis of cardiac disease) and non-cardiac patients. [Time frame: 48 hours]
  • Changes in Peripheric Perfusion Index(PPI) values in patients who experience spontaneous breathing trial(SBT) failure. [Time frame: 48 hours]

Eligibility criteria

Inclusion criteria

  • Patients who have been on mechanical ventilation for at least 48 hours
  • Patients over 18 years of age who are planned to undergo extubation following a spontaneous breathing trial (SBT)
  • Patients or their legal representatives who provide informed consent to participate in the study

Exclusion criteria

  • Patients for whom extubation is not planned due to hemodynamic instability
  • Patients with peripheral vascular disease or a history of hand surgery
  • Patients who die or cannot be followed up during the study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Gaziosmanpaşa Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07120672 · Gaziosmanpaşa TREH, VD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗