Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation.
The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.
Eligibility criteria
Qualifiers
PSV initiated during the last 24 hours;
Mechanical ventilation expected to be required for at least 24-48 h by responsible physicians;
The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure PEEP);
No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4.
Disqualifiers
Age younger than 18 years old;
Initiation of PSV before ICU admission;
Duration of mechanical ventilation longer than 7 days before enrollment;
History of neuromuscular diseases;
Trial design
Treatments tested in this trial
- PMI-targeted pressure support setting and adjustment
- VT/RR-targeted pressure support setting and adjustment
Treatment groups
619 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov