Mechanically Ventilated PatientsPV-INTERACTNCT07896967
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
An observational study of Mechanically Ventilated Patients and Acute Respiratory Failure (ARF), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The goal of this observational study is to learn whether breathing effort and patient-ventilator asynchrony (PVA) during the transition phase are associated with clinical outcomes in mechanically ventilated adults.The main questions it aims to answer are: Is the level and change in breathing effort associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
- What is being tested?
- PVA classification software
- How many people
- 250 participants
- Where
- 1 siteChile
- Study dates
- Nov 2026to Oct 2029
- 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: Adult patients admitted to the ICU that receive invasive mechanical ventilation entering the transition phase
Who may be able to join
- Adult patients (>=18 years) intubated and receiving invasive mechanical ventilation delivered through an endotracheal tube within the first 48 hours from initiation of ventilation.
- No immediate plan for extubation within the next 48 hours, a determined by the treating clinical team.
- Patients clinically stable entering the transition phase of mechanical ventilation *
- For prospective enrollment and initiation of active monitoring, the transition phase will be identified clinically. A patient will be considered to be entering the transition phase when there is improvement or partial resolution of the acute phase and the treating team initiates at least one clinical action indicating an intention to allow greater spontaneous respiratory participation. These actions may include: reducing or discontinuing sedation, decreasing the set respiratory rate, changing to a ventilatory mode allowing greater patient participation, decision to assess spontaneous breathing or advance liberation from mechanical ventilation.
- For the final analysis, the physiological onset of the transition phase will be determined retrospectively from the continuous ventilator waveform recordings. It will be defined as the first sustained 30-minute period during which at least 50% of ventilator-delivered breaths are triggered by the patient. This physiological criterion will be used to align individual trajectories and define the analytical onset of transition
Who cannot join
- Pre-existing neurological or muscular conditions (e.g., subarachnoid hemorrhage, diaphragm paralysis)
- History of recovered cardiocirculatory arrest
- Extra-corporeal membrane oxygenation (ECMO)
- Current pregnancy
- Documented intellectual or psychiatric disability prior to hospitalization
- A decision to withhold or withdraw life-sustaining treatment
- Patients undergoing a second episode of mechanical ventilation during the same hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Hospital Clinico UC
Santiago, Santiago Metropolitan
Felipe Damiani, PhD, Msc, Physioterapy, +56966698823, lfdamiani@gmail.com
About this study
Official title: Impact of Inspiratory Effort and Patient-Ventilator INTERACtion During the Transition Phase of Mechanical Ventilation on Clinical Outcomes: the PV-INTERACT Study
The goal of this observational study is to learn whether breathing effort and patient-ventilator asynchrony (PVA) during the transition phase are associated with clinical outcomes in mechanically ventilated adults.The main questions it aims to answer are:
- Is the level and change in breathing effort associated with successful liberation from mechanical ventilation?
- How often does PVA occur during the transition phase?
- Are breathing effort and PVA associated with patient outcomes?
These questions will be assessed using physiological and clinical data collected during the transition phase of mechanical ventilation. Breathing effort will be measured twice daily using a non-invasive airway pressure measurement, while ventilator waveforms will be continuously monitored to detect PVA. Participants will be followed up at day 28 and day 90.
Read the detailed description
The transition phase of mechanical ventilation is a critical but understudied period in which spontaneous breathing gradually increases as ventilatory support is reduced. Both insufficient and excessive inspiratory effort, as well as patient-ventilator asynchrony (PVA), may contribute to lung and diaphragm injury, prolonged mechanical ventilation and worse clinical outcomes. However, the relationship between inspiratory effort, PVA and outcomes during this phase remains incompletely understood.
In this multicenter prospective observational study, the investigators will assess inspiratory effort using airway occlusion pressure (ΔPocc) and continuously monitor patient-ventilator interaction using ventilator waveform recordings. Adult patients entering the transition phase of invasive mechanical ventilation will be followed during this period and through day 90. ΔPocc will be measured twice daily, while PVA will be assessed continuously using breath-by-breath monitoring.
The primary outcome will be time to successful liberation from mechanical ventilation within 28 days. Secondary outcomes will include ventilator-free days at day 28, ICU and hospital length of stay, 28- and 90-day mortality, weaning failure or reintubation, tracheostomy, and the incidence and magnitude of patient-ventilator asynchrony.
- Being tested
- PVA classification software
- Keywords
- Patient-ventilator asynchrony, Transition phase, Mechanical ventilation, Respiratory effort, Work of Breathing
- Medical subject headings
- Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVA classification softwareOther
Patients will receive standard care. Clinical and physiological data will be collected systematically for up to 7 days during the transition phase.Patient-ventilator asynchrony will be continuously monitored using a using dedicated offline software (DeepBreath platform via the BreathBox device). Inspiratory breathing effort will be quantified using ΔPocc, performed during the morning (08:00-10:00 h) and afternoon (18:00-20:00 h) assessment periods
| Study group | Role | What they receive |
|---|---|---|
| Adult patients admitted to the ICU that receive invasive mechanical ventilation | * Adult patients (>=18 years) intubated and receiving invasive mechanical ventilation delivered through an endotracheal tube within the first 48 hours from initiation of ventilation.
* No immediate plan for extubation within the next 48 hours, a determined by the treating clinical team.
* Patients clinically stable entering the transition phase of mechanical ventilation Receives: Other: PVA classification software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful liberation from mechanical ventilation within 28 days of enrollment
Defined as the time from entry into the transition phase (study enrollment) to the first episode of sustained extubation, lasting at least 7 days
Measured: 28 days
Secondary outcomes (15)
Ventilator free days (at day 28)
Number of ventilator free days at day 28
Measured: 28 days
ICU length of stay (28 days)
Length of ICU stay, measured in days from enrollment
Measured: 28 days
ICU length of stay (at day 90)
ICU length of stay, measured in days from enrollment
Measured: 90 days
Mortality at day 28
Mortality at day 28
Measured: 28 days
Mortality at day 90
Mortality at day 90
Measured: 90 days
Incidence of weaning failure or reintubation
reintubation within 7 days after extubation.
Measured: 7 days
Rate of complications
including tracheostomy and resumption of sedatives
Measured: 28 days
Physiological characterization
based on different inspiratory effort levels (ΔPocc)
Measured: 7 days
Incidence (AI) of patient-ventilator asynchrony
Number of asynchronous respiratory cycles, expressed as a proportion of the total respiratory cycles recorded, overall and by PVA type.
Measured: 7 days
Mechanical ventilation settings
Main parameters obtained from the mechanical ventilator to describe the population such as Tidal volume (liters), PEEP(cmH2O), peak pressure (cmH2O), pressure support (cmH2O), inspiratory time (seconds), respiratory rate (n/min), FIO2 (%), plateau pressure(cmH2O), driving pressure(cmH2O), static compliance (ml/cmH20)
Measured: 7 days
Gas exchange parameters
e.g. PaO2 (mmhg), PaCO2 (mmhg) bicarbonate (mEq/L)
Measured: 7 days
Relevant medication
e.g. vasoactive agents, delirium related medication
Measured: 7 days
Illness severity score (SOFA-score)
SOFA-score. This score ranges from 0-24, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention.
Measured: 7 days
Use of sedatives (cumulative dose and type)
Measured: 7 days
Reported delirium
CAM-ICU
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universidad Catolica, Hospital Civil Fray Antonio Alcalde, University Hospital Padova, Clínica San Carlos de Apoquindo
- Responsible party
- Sponsor
- Investigators
- Felipe Damiani, PT, Msc, PhD, Principal investigator, Escuela de Ciencias de la Salud, Pontificia Universidad Católica de Chile Santiago, ChileEduardo Kattan, MD, PhD, Study chair, Departamento de Medicina Intensiva, Pontificia Universidad Católica de Chile Santiago, ChileAlejandro Bruhn, MD, PhD, Study chair, Departamento de Medicina Intensiva, Pontificia Universidad Católica de Chile Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896967
- Sponsor's protocol ID
- 250625025
- Other IDs
- 1261566
- Acronym
- PV-INTERACT
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspiratory Effort and Patient-Ventilator INTERACtion During the Transition Phase of Mechanical Ventilation on Clinical Outcomes: the PV-INTERACT Study
- ClinicalTrials.gov ID
- NCT07896967
- Acronym / sponsor ID
- PV-INTERACT / 250625025
- Keywords
- Patient-ventilator asynchrony, Transition phase, Mechanical ventilation, Respiratory effort, Work of Breathing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Hospital Clinico Universidad Catolica, Hospital Civil Fray Antonio Alcalde, University Hospital Padova, Clínica San Carlos de Apoquindo
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 27 Oct 2026 (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 observational study is to learn whether breathing effort and patient-ventilator asynchrony (PVA) during the transition phase are associated with clinical outcomes in mechanically ventilated adults.The main questions it aims to answer are:
- Is the level and change in breathing effort associated with successful liberation from mechanical ventilation?
- How often does PVA occur during the transition phase?
- Are breathing effort and PVA associated with patient outcomes?
These questions will be assessed using physiological and clinical data collected during the transition phase of mechanical ventilation. Breathing effort will be measured twice daily using a non-invasive airway pressure measurement, while ventilator waveforms will be continuously monitored to detect PVA. Participants will be followed up at day 28 and day 90.
Detailed description
The transition phase of mechanical ventilation is a critical but understudied period in which spontaneous breathing gradually increases as ventilatory support is reduced. Both insufficient and excessive inspiratory effort, as well as patient-ventilator asynchrony (PVA), may contribute to lung and diaphragm injury, prolonged mechanical ventilation and worse clinical outcomes. However, the relationship between inspiratory effort, PVA and outcomes during this phase remains incompletely understood.
In this multicenter prospective observational study, the investigators will assess inspiratory effort using airway occlusion pressure (ΔPocc) and continuously monitor patient-ventilator interaction using ventilator waveform recordings. Adult patients entering the transition phase of invasive mechanical ventilation will be followed during this period and through day 90. ΔPocc will be measured twice daily, while PVA will be assessed continuously using breath-by-breath monitoring.
The primary outcome will be time to successful liberation from mechanical ventilation within 28 days. Secondary outcomes will include ventilator-free days at day 28, ICU and hospital length of stay, 28- and 90-day mortality, weaning failure or reintubation, tracheostomy, and the incidence and magnitude of patient-ventilator asynchrony.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted to the ICU that receive invasive mechanical ventilation | – | Other: PVA classification software* Adult patients (>=18 years) intubated and receiving invasive mechanical ventilation delivered through an endotracheal tube within the first 48 hours from initiation of ventilation. * No immediate plan for extubation within the next 48 hours, a determined by the treating clinical team. * Patients clinically stable entering the transition phase of mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU that receive invasive mechanical ventilation entering the transition phase
Key inclusion criteria (5 listed)
- Adult patients (>=18 years) intubated and receiving invasive mechanical ventilation delivered through an endotracheal tube within the first 48 hours from initiation of ventilation.
- No immediate plan for extubation within the next 48 hours, a determined by the treating clinical team.
- Patients clinically stable entering the transition phase of mechanical ventilation *
- For prospective enrollment and initiation of active monitoring, the transition phase will be identified clinically. A patient will be considered to be entering the transition phase when there is improvement or partial resolution of the acute phase and the treating team initiates at least one clinical action indicating an intention to allow greater spontaneous respiratory participation. These actions may include: reducing or discontinuing sedation, decreasing the set respiratory rate, changing to a ventilatory mode allowing greater patient participation, decision to assess spontaneous breathing or advance liberation from mechanical ventilation.
- For the final analysis, the physiological onset of the transition phase will be determined retrospectively from the continuous ventilator waveform recordings. It will be defined as the first sustained 30-minute period during which at least 50% of ventilator-delivered breaths are triggered by the patient. This physiological criterion will be used to align individual trajectories and define the analytical onset of transition
Key exclusion criteria (7 listed)
- Pre-existing neurological or muscular conditions (e.g., subarachnoid hemorrhage, diaphragm paralysis)
- History of recovered cardiocirculatory arrest
- Extra-corporeal membrane oxygenation (ECMO)
- Current pregnancy
- Documented intellectual or psychiatric disability prior to hospitalization
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 |
|---|---|---|
| PVA classification softwarePatients will receive standard care. Clinical and physiological data will be collected systematically for up to 7 days during the transition phase.Patient-ventilator asynchrony will be continuously monitored using a using dedicated offline software (DeepBreath platform via the BreathBox device). Inspiratory breathing effort will be quantified using ΔPocc, performed during the morning (08:00-10:00 h) and afternoon (18:00-20:00 h) assessment periods | Other | Adult patients admitted to the ICU that receive invasive mechanical ventilation |
Primary outcome
Successful liberation from mechanical ventilation within 28 days of enrollment
Time frame: 28 days
Defined as the time from entry into the transition phase (study enrollment) to the first episode of sustained extubation, lasting at least 7 days
15 secondary outcomes
Ventilator free days (at day 28)
Time frame: 28 days
ICU length of stay (28 days)
Time frame: 28 days
ICU length of stay (at day 90)
Time frame: 90 days
Mortality at day 28
Time frame: 28 days
Mortality at day 90
Time frame: 90 days
Incidence of weaning failure or reintubation
Time frame: 7 days
Rate of complications
Time frame: 28 days
Physiological characterization
Time frame: 7 days
Incidence (AI) of patient-ventilator asynchrony
Time frame: 7 days
Mechanical ventilation settings
Time frame: 7 days
Gas exchange parameters
Time frame: 7 days
Relevant medication
Time frame: 7 days
Illness severity score (SOFA-score)
Time frame: 7 days
Use of sedatives (cumulative dose and type)
Time frame: 7 days
Reported delirium
Time frame: 7 days
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mechanically Ventilated Patients
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
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.
Felipe Damiani, PT, Msc, PhD principal investigator
Escuela de Ciencias de la Salud, Pontificia Universidad Católica de Chile Santiago, Chile
Eduardo Kattan, MD, PhD study chair
Departamento de Medicina Intensiva, Pontificia Universidad Católica de Chile Santiago, Chile
Alejandro Bruhn, MD, PhD study chair
Departamento de Medicina Intensiva, Pontificia Universidad Católica de Chile Santiago, Chile
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 Mechanically Ventilated Patients and Acute Respiratory Failure (ARF), run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Oct 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 Chile. 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 Felipe Damiani, PT, Msc, PhD (+56966698823 ext. +56 9 6669 882, lfdamiani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful liberation from mechanical ventilation within 28 days of enrollment (time frame: 28 days). 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 27 Oct 2026.