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Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial

ConditionsCritical CareAcute Hypoxic Respiratory FailureVentilator-Induced Lung Injury
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PMI-targeted pressure support setting and adjustment

    Procedure/Surgery

    During PSV, the pressure support is set and adjusted to a PMI target between 0 and 2 cmH2O.

  • VT/RR-targeted pressure support setting and adjustment

    Procedure/Surgery

    During PSV, pressure support is set and adjusted according to a VT/RR target of VT between 6 and 8 ml/kg predicted body weight, RR between 20 and 35 breaths/min, and no signs of respiratory distress.

Treatment groups

619 Participants
are divided into 2 treatment groups
Group A: PMI-targeted groupExperimental treatment 1 intervention
Group B: VT/RR-targeted groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator-free days (VFDs) at day 28 after enrollment.

The primary outcome is the ventilator-free days (VFDs) at day 28 after enrollment. The calculation of VFDs will follow the standard recommendations.

Time frame
28 days

Secondary outcomes

1

Duration of mechanical ventilation after enrollment

Defined as the time intervals from enrollment to successful weaning. For patients with re-intubation or restoration of mechanical ventilation via tracheostomy within seven days after extubation and discontinuation of ventilation, the thereafter duration will be added.

Time frame
28 days
2

The time before the first spontaneous breathing trial

Defined as the time interval from intubation and mechanical ventilation to the first spontaneous breathing trial attempt.

Time frame
28 days
3

Weaning time

Defined as the time from the first SBT attempt to successful discontinuation of mechanical ventilation.

Time frame
28 days
4

Frequency of prolonged weaning

Prolonged weaning is defined as that weaning is still not terminated 7 days after the first separation attempt.

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov
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