NCT07120672

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

May 7, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

perfusion indexweaningıcu

Outcome Measures

Primary Outcomes (1)

  • • The ability of Peripheric Perfusion Index(PPI) measured 1 hour after extubation to predict extubation failure within 48 hours following extubation.

    48 hours

Secondary Outcomes (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.

    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.

    48 hours

  • Changes in Peripheric Perfusion Index(PPI) values in patients who experience spontaneous breathing trial(SBT) failure.

    48 hours

Interventions

patients were monitored for reentubation for 48 hours.

patients were monitored for reentubation for 48 hours.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have been on mechanical ventilation for at least 48 hours and 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

May 7, 2025

First Posted

August 13, 2025

Study Start

May 8, 2025

Primary Completion

August 15, 2025

Study Completion

August 30, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations