NCT06526598

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 25, 2024

Last Update Submit

January 19, 2026

Conditions

Critical CareAcute Hypoxic Respiratory FailureVentilator-Induced Lung Injury

Keywords

pressure support ventilationpressure muscle indexinspiratory effort

Outcome Measures

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.

    28 days

Secondary Outcomes (8)

  • Duration of mechanical ventilation after enrollment

    28 days

  • The time before the first spontaneous breathing trial

    28 days

  • Weaning time

    28 days

  • Frequency of prolonged weaning

    28 days

  • ICU mortality

    28 days

  • +3 more secondary outcomes

Study Arms (2)

PMI-targeted group

EXPERIMENTAL

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

VT/RR-targeted group

ACTIVE COMPARATOR

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

Interventions

PMI-targeted pressure support setting and adjustmentPROCEDURE

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

PMI-targeted group
VT/RR-targeted pressure support setting and adjustmentPROCEDURE

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.

VT/RR-targeted group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Clinical suspicion of increased intracranial pressure;
  • Extracorporeal support;
  • Moribund conditions;
  • Refusal by the ICU physicians or the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39582975DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jian-Xin Zhou, MD

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 6392 6666zhoujx.cn@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

January 19, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)