Weaning Mechanical VentilationNCT07268989
Evaluation of Mechanical Power and Ventilator Parameters to Predict Weaning Success in the Intensive Care Unit
An observational study of Weaning Mechanical Ventilation and Mechanical Power, run by Anıl Berkay Balıtatlı at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Mechanical Ventilation, Mechanical Power, Negative Inspiratory Force
- What is being tested?
- Mechanical power
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 7 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients who are receiving invasive mechanical ventilation in the intensive care unit (ICU) and are scheduled for planned extubation based on standard clinical weaning criteria. All participants must be hemodynamically stable and able to undergo bedside ventilator-based respiratory assessment, including mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI), prior to extubation.
Who may be able to join
- -
- Age ≥ 18 years (adult patient population)
- Patients receiving invasive mechanical ventilation in the intensive care unit
- Having been intubated for at least 24 hours
- Patients for whom the clinical team has decided extubation and who meet the following weaning criteria:
- Stable respiratory parameters (FiO₂ ≤ 50%, PEEP ≤ 7 cmH₂O, SpO₂ ≥ 92%)
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- Hemodynamic stability (no inotropic support or minimal/stable dose)
- Stable acid-base balance
- Adequate secretion control
- Technically suitable ventilator and measurement conditions
- Written informed consent obtained from the patient or legal representative
Who cannot join
- Patients with any of the following conditions will be excluded:
- and
- Individuals under 18 years of age
- Pregnant patients
- Patients who do not meet the weaning criteria
- Tracheostomized patients
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- Neuromuscular diseases (e.g., Guillain-Barré syndrome, Duchenne muscular dystrophy, etc.)
- Technical inadequacy preventing correct ventilator measurements
- Significant asynchrony (e.g., auto-PEEP, double triggering, ineffective triggering, cycle asynchrony, auto-triggering)
- Patients without an extubation plan or those receiving palliative care
- RASS ≤ -2 (excessive sedation) for PSV mode measurements
- RASS ≥ +2 (agitation) for PSV-CPAP mode measurements
- Patients with delirium for PSV-CPAP mode measurements
- Patients who cannot provide consent, have no legal representative, or whose representative refuses consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303
About this study
Official title: Evaluation of Mechanical Power to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
The goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are:
Can the mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes?
Read more
Participants will:
- Be adult ICU patients planned for weaning from mechanical ventilation.
- Undergo bedside ventilatory assessment within 2 hours after meeting clinical weaning criteria.
- Have the following respiratory parameters measured: MP, P0.1, NIF, and RSBI.
- Be monitored for 48 hours after extubation to assess weaning success (defined as no need for reintubation after extubation)
Read the detailed description
This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.
Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.
All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.
Data collection will include:
Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.
Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II scores, ventilator settings, and duration of mechanical ventilation.
Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.
This study does not involve any interventions beyond standard ICU care. Ventilator-based respiratory assessments are routinely performed in ICU settings and pose no additional risk to participants.
The results may support the integration of load-drive-capacity assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.
- Conditions
- Weaning Mechanical Ventilation, Mechanical Power, Negative Inspiratory Force, Airway Occlusion Pressure
- Being tested
- Mechanical power
- Keywords
- Mechanical power, Weaning mechanical ventilation, Negative inspiratory, Airway occlusion pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical powerDiagnostic test
Non-invasive bedside evaluation of respiratory load, neural drive, and inspiratory muscle capacity using mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI).
- Measurements will be performed once within 2 hours prior to the extubation decision as part of routine ICU respiratory monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Mechanically Ventilated ICU Patients Undergoing Weaning | Adult patients receiving mechanical ventilation in the intensive care unit (ICU) who meet clinical criteria for planned weaning and extubation. All patients will undergo bedside ventilator-based respiratory assessment to evaluate mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI) prior to extubation. Receives: Diagnostic Test: Mechanical power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Power (MP)
Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
Measured: 48 hour
Secondary outcomes (4)
Airway Occlusion Pressure at 100 ms (P0.1)
P0.1, an indicator of the patient's neural inspiratory drive that reflects the initial negative pressure generated at the start of a breath, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
Measured: 48 hour
Negative Inspiratory Force (NIF)
NIF, a measure of maximal inspiratory muscle strength reflecting the patient's ability to generate negative pressure, will be obtained prior to planned extubation and evaluated in relation to extubation outcomes
Measured: 48 hour
Rapid Shallow Breathing Index (RSBI)
RSBI, an established index that incorporates respiratory rate and tidal volume to characterize rapid and shallow breathing, will be recorded prior to planned extubation and evaluated in relation to extubation outcomes
Measured: 48 hour
Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio)
The MP/NIF ratio, reflecting the relationship between ventilatory mechanical load and inspiratory muscle capacity, will be calculated prior to planned extubation and evaluated in relation to extubation outcomes
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jul 2025
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mechanical VentilationStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anıl Berkay Balıtatlı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anıl Berkay Balıtatlı, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268989
- Sponsor's protocol ID
- Mechanical Power
- Status last verified
- May 2026
- First submitted
- 25 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanical Power to Predict Weaning Success in the Intensive Care Unit: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07268989
- Acronym / sponsor ID
- Mechanical Power
- Conditions
- Weaning Mechanical Ventilation, Mechanical Power, Negative Inspiratory Force, Airway Occlusion Pressure
- Keywords
- Mechanical power, Weaning mechanical ventilation, Negative inspiratory, Airway occlusion pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anıl Berkay BalıtatlıUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 8 Dec 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 goal of this prospective observational study is to evaluate whether ventilator-based respiratory parameters can predict weaning success in adult intensive care unit (ICU) patients who are mechanically ventilated. The main questions it aims to answer are:
Can the mechanical power (MP) value predict successful extubation? Do other respiratory parameters-airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI)-provide additional prognostic value for weaning outcomes?
Participants will:
- Be adult ICU patients planned for weaning from mechanical ventilation.
- Undergo bedside ventilatory assessment within 2 hours after meeting clinical weaning criteria.
- Have the following respiratory parameters measured: MP, P0.1, NIF, and RSBI.
- Be monitored for 48 hours after extubation to assess weaning success (defined as no need for reintubation after extubation)
Detailed description
This is a prospective, observational, single-center study designed to investigate whether ventilator-derived physiological measurements can predict weaning success in mechanically ventilated adult ICU patients. The primary objective is to determine the prognostic value of mechanical power (MP) in forecasting successful extubation.
Secondary objectives include the evaluation of additional respiratory parameters such as airway occlusion pressure (P0.1), negative inspiratory force (NIF), the rapid shallow breathing index (RSBI), and the mechanical power/negative inspiratory force ratio (MP/NIF). These parameters will be measured at the bedside within 2 hours after patients meet clinical weaning criteria and are hemodynamically stable.
All participants will be monitored for 48 hours after extubation. Weaning success is defined as the ability to sustain spontaneous breathing without the need for reintubation after extubation during this period.
Data collection will include:
Respiratory measurements obtained from the ventilator: MP, P0.1, NIF, RSBI, and MP/NIF.
Demographic and clinical data: age, sex, BMI, ICU admission diagnosis, APACHE II scores, ventilator settings, and duration of mechanical ventilation.
Post-extubation follow-up: reintubation, non-invasive ventilation or high-flow oxygen use, SpO₂ values, blood gas analysis, and vital signs.
This study does not involve any interventions beyond standard ICU care. Ventilator-based respiratory assessments are routinely performed in ICU settings and pose no additional risk to participants.
The results may support the integration of load-drive-capacity assessment into routine ICU weaning protocols and improve clinical decision-making by reducing the incidence of weaning failure and associated complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated ICU Patients Undergoing Weaning | – | Diagnostic Test: Mechanical powerAdult patients receiving mechanical ventilation in the intensive care unit (ICU) who meet clinical criteria for planned weaning and extubation. All patients will undergo bedside ventilator-based respiratory assessment to evaluate mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI) prior to extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are receiving invasive mechanical ventilation in the intensive care unit (ICU) and are scheduled for planned extubation based on standard clinical weaning criteria. All participants must be hemodynamically stable and able to undergo bedside ventilator-based respiratory assessment, including mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI), prior to extubation.
Key inclusion criteria (11 listed)
- -
- Age ≥ 18 years (adult patient population)
- Patients receiving invasive mechanical ventilation in the intensive care unit
- Having been intubated for at least 24 hours
- Patients for whom the clinical team has decided extubation and who meet the following weaning criteria:
Key exclusion criteria (14 listed)
- Patients with any of the following conditions will be excluded:
- and
- Individuals under 18 years of age
- Pregnant patients
- Patients who do not meet the weaning criteria
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 |
|---|---|---|
| Mechanical powerNon-invasive bedside evaluation of respiratory load, neural drive, and inspiratory muscle capacity using mechanical power (MP), airway occlusion pressure (P0.1), negative inspiratory force (NIF), and the rapid shallow breathing index (RSBI). • Measurements will be performed once within 2 hours prior to the extubation decision as part of routine ICU respiratory monitoring. | Diagnostic test | Mechanically Ventilated ICU Patients Undergoing Weaning |
Primary outcome
Mechanical Power (MP)
Time frame: 48 hour
Mechanical Power (MP), a ventilator-derived estimate of the total mechanical energy transferred to the respiratory system per unit time, will be measured prior to planned extubation and evaluated in relation to extubation outcomes
4 secondary outcomes
Airway Occlusion Pressure at 100 ms (P0.1)
Time frame: 48 hour
Negative Inspiratory Force (NIF)
Time frame: 48 hour
Rapid Shallow Breathing Index (RSBI)
Time frame: 48 hour
Mechanical Power to Negative Inspiratory Force Ratio (MP/NIF Ratio)
Time frame: 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Weaning Mechanical Ventilation and Mechanical Power, run by Anıl Berkay Balıtatlı 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 18 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Power (MP) (time frame: 48 hour). 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 18 May 2026.