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

A Cluster Randomized Trial on Inspiratory Effort-Based Pressure Support Adjustment Strategy in Patients Undergoing Assisted Mechanical Ventilation

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; Critical Care; Acute Hypoxic Respiratory Failure
• Intervention / Treatment: Procedure: PMI-targeted pressure support setting and adjustment; Procedure: VT/RR-targeted pressure support setting and adjustment

Detailed Description

Pressure-support ventilation (PSV) is widely used in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. Traditionally, pressure support levels are set according to tidal volume (VT) and respiratory rate (RR). However, previous studies have shown that over-assistance under PSV is not uncommon based on this setting strategy. Pressure muscle index (PMI) is an inspiratory effort monitoring, which can be easily obtained on the ventilator screen at the bedside.

Aim:

The aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional approach, can improve clinical outcomes in adult participants undergoing PSV.

Design:

This is a two-arm cluster randomized trial in 18 clusters randomized 1:1 to pressure support setting by a PMI-targeted strategy or a traditional VT/RR-targeted strategy.

Population:

Patients with acute hypoxic respiratory failure who have been intubated within seven days and undergoing PSV within 24 hours will be enrolled.

Intervention:

During the study, a general standard of care for mechanical ventilation will be followed, including the transition of control modes to PSV, the principle PSV settings (trigger, cycle-off, fraction of inspired oxygen, and positive end-expiratory pressure), rescue backup of controlled ventilation, performance of spontaneous breathing trial, and weaning and extubation.

In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths/min.

In the PMI-targeted group, the pressure support is adjusted according to the PMI between 0 and 2 cmH2O.

During the study period in the two groups, pressure support adjustment will be performed at least twice daily.

The intervention will be implemented over 24 months.

Training:

After randomization, a four-week comprehensive training program will be conducted for all staff in the participating ICUs before the formal start of the trial.

Outcomes:

The primary outcome is the ventilator free day during 28 days. Secondary outcomes include total duration of mechanical ventilation, the time before the first spontaneous breathing trial, weaning time, frequency of prolonged and failed weaning, frequency of mechanical ventilation longer than 21 days, length of stay in the ICU and hospital, ICU mortality, hospital mortality, and 28-day mortality.

Study sites:

The study will be conducted in 18 ICUs in university-affiliated hospitals in three provinces in China: Beijing, Tianjin, and Hebei.

• Study Type: Interventional
• Enrollment (Estimated): 619
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian-Xin Zhou, MD; Phone Number: 8610 6392 6666; Email: zhoujx.cn@icloud.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100038
      • Recruiting
      • Beijing Shijitan Hospital
      • Contact: Jian-Xin Zhou, MD; Phone Number: 8610 6392 6666; Email: zhoujx.cn@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Mechanically ventilated patients, who are admitted to the ICU with acute hypoxic respiratory failure, will be consecutively screened daily at 08:00-10:00 morning rounds.

Inclusion criteria:

1. PSV initiated during the last 24 hours;
2. Mechanical ventilation expected to be required for at least 24-48 h by responsible physicians;
3. 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);
4. 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.

Exclusion criteria included:

1. Age younger than 18 years old;
2. Initiation of PSV before ICU admission;
3. Duration of mechanical ventilation longer than 7 days before enrollment;
4. History of neuromuscular diseases;
5. Clinical suspicion of increased intracranial pressure;
6. Extracorporeal support;
7. Moribund conditions;
8. Refusal by the ICU physicians or the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMI-targeted group; The participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the PMI target.	Procedure: PMI-targeted pressure support setting and adjustment; During PSV, the pressure support is set and adjusted to a PMI target between 0 and 2 cmH2O.
Active Comparator: VT/RR-targeted group; The participants will be treated according to the standard of care for mechanical ventilation. During PSV, pressure support is set and adjusted according to the VT/RR target.	Procedure: VT/RR-targeted pressure support setting and adjustment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
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.	28 days
Weaning time	Defined as the time from the first SBT attempt to successful discontinuation of mechanical ventilation.	28 days
Frequency of prolonged weaning	Prolonged weaning is defined as that weaning is still not terminated 7 days after the first separation attempt.	28 days
ICU mortality	Death in the ICU.	28 days
Hospital mortality	Death in the hospital.	28 days
Length of stay in the ICU	Defined as the time interval from enrollment to discharge from ICU or death.	28 days
Length of stay in the hospital	Defined as the time interval from enrollment to discharge from hospital or death.	28 days

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Jian-Xin Zhou, MD, Capital Medical University

Publications and helpful links

General Publications

• Lu WY, Miao MY, Gao R, Yang YL, Zhang L, Weng L, Zhu FX, Liu L, Zhou JX. A cluster randomized trial on inspiratory effort-targeted pressure support adjustment strategy in patients undergoing assisted mechanical ventilation: protocol for the IT-PSV study. Front Med (Lausanne). 2024 Nov 8;11:1483976. doi: 10.3389/fmed.2024.1483976. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pressure support ventilation; inspiratory effort; pressure muscle index
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: IIT2024-029-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No