An observational study in Mechanically Ventilated Patients and Acute Respiratory Failure (ARF), sponsored by Pontificia Universidad Catolica de Chile. Not yet recruiting at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
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:
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.
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.
24 studies on the registry are indexed under Patient-Ventilator Asynchrony; 11 are open to participants now.
This study's planned enrollment of 250 is above the median of 40 across 13 observational studies indexed under Patient-Ventilator Asynchrony.
Browse Patient-Ventilator Asynchrony studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to the ICU that receive invasive mechanical ventilation entering the transition phase
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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*
Exclusion Criteria:
* 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
Other: PVA classification software
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
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
Time frame: 28 days
Ventilator free days (at day 28)
Number of ventilator free days at day 28
Time frame: 28 days
ICU length of stay (28 days)
Length of ICU stay, measured in days from enrollment
Time frame: 28 days
ICU length of stay (at day 90)
ICU length of stay, measured in days from enrollment
Time frame: 90 days
Mortality at day 28
Mortality at day 28
Time frame: 28 days
Mortality at day 90
Mortality at day 90
Time frame: 90 days
Incidence of weaning failure or reintubation
reintubation within 7 days after extubation.
Time frame: 7 days
Rate of complications
including tracheostomy and resumption of sedatives
Time frame: 28 days
Physiological characterization
based on different inspiratory effort levels (ΔPocc)
Time frame: 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.
Time frame: 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)
Time frame: 7 days
Gas exchange parameters
e.g. PaO2 (mmhg), PaCO2 (mmhg) bicarbonate (mEq/L)
Time frame: 7 days
Relevant medication
e.g. vasoactive agents, delirium related medication
Time frame: 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.
Time frame: 7 days
Use of sedatives (cumulative dose and type)
Time frame: 7 days
Reported delirium
CAM-ICU
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2029, 35 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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