Perfusion IndexNCT07120672
PPI in Weaning Prediction
An observational study of Perfusion Index and Weaning of Mechanical Ventilation, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion Index, Weaning of Mechanical Ventilation, ICU
- What is being tested?
- patients were monitored for reentubation for 48 hours. and weaning group
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2025to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul, 34000
Gaziosmanpaşa Training and Research Hospital Gaziosmanpaşa Training and Research Hospital, +90 212 945 30 00, info@gopeah.com
Veysel Dinç Assistant Prof.
About this study
Official title: The Role of Peripheral Perfusion Index as a Predictive Factor During Weaning Process
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.
Read the 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.
- Conditions
- Perfusion Index, Weaning of Mechanical Ventilation, ICU
- Being tested
- patients were monitored for reentubation for 48 hours., weaning group
- Keywords
- perfusion index, weaning, ıcu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients were monitored for reentubation for 48 hours.Other
patients were monitored for reentubation for 48 hours.
weaning groupOther
patients were monitored for reentubation for 48 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
• The ability of Peripheric Perfusion Index(PPI) measured 1 hour after extubation to predict extubation failure within 48 hours following extubation.
Measured: 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.
Measured: 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.
Measured: 48 hours
Changes in Peripheric Perfusion Index(PPI) values in patients who experience spontaneous breathing trial(SBT) failure.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start8 May 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, veysel Dinç, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120672
- Sponsor's protocol ID
- Gaziosmanpaşa TREH, VD
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Peripheral Perfusion Index as a Predictive Factor During Weaning Process
- ClinicalTrials.gov ID
- NCT07120672
- Acronym / sponsor ID
- Gaziosmanpaşa TREH, VD
- Conditions
- Perfusion Index, Weaning of Mechanical Ventilation, ICU
- Keywords
- perfusion index, weaning, ıcu
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 8 May 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients were monitored for reentubation for 48 hours.patients were monitored for reentubation for 48 hours. | Other | – |
| weaning grouppatients were monitored for reentubation for 48 hours. | Other | – |
Primary outcome
• 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
3 secondary outcomes
• 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perfusion Index and Weaning of Mechanical Ventilation, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veysel Dinç (+90 545 745 3472, drvdinc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.