A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial

NCT06769360 | Recruiting

• 1 other identifier: KY2023-206-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure support ventilation (PSV) is one of the most frequently used ventilator modes in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. In clinical practice, the pressure support level is usually set and adjusted according to tidal volume (VT) and respiratory rate (RR). However, these parameters may not fully represent the patient's effort. Previous studies have shown that pressure muscle index (PMI), which is measured as the difference between the peak and plateau airway pressure during an end-inspiratory airway occlusion, could reliably determine the low and high inspiratory effort during PSV. However, the comparative effectiveness of these two pressure support level setting strategies remains uncertain. Our aim is to explore clinical and implementation factors relevant to a future definitive randomized controlled trial to evaluate PMI - and VT/RR - pressure support level setting strategies. The Inspiratory effort-targeted pressure support ventilation pragmatic pilot trial will test clinician adherence and to explore clinical outcomes. Two centers are included in a pragmatic sequential cluster crossover pilot trial. We enrolled all eligible adults with acute respiratory failure requiring mechanical ventilation admitted to ICU. The pressure support level setting strategy was assigned according to the epoch. The first trial epoch will be assigned to VTRR - pressure support level setting strategy for 4 weeks. The washout week between the two epochs will be 4 weeks. Then sequentially, it will be crossed over to PMI - pressure support level setting strategy for 4 weeks.

• In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg PBW and RR between 20 and 35 breaths/min until day 28 or death or performance of spontaneous breathing trial (SBT).
• In the PMI-targeted group, the pressure support is adjusted according to PMI between 0 and 2 cmH2O until day 28 or death or performance of SBT. We will also survey clinicians to understand potential facilitators and barriers to conducting a definitive randomized trial.

Conditions

Critical Care; Acute Hypoxic Respiratory Failure; Ventilator Lung

Keywords

pressure support ventilation; pressure muscle index; inspiratory effort

Outcome Measures

Primary Outcomes (1)

• Feasibility of PMI target pressure support level setting strategy

  Defined as 75% of the test points in which PMI can reach 0-2 cmH2O.

  1 year

Secondary Outcomes (10)

• Feasibility of VT/RR target pressure support level setting strategy

  1 year

• Ventilator-free days (VFDs)

  1 year

• Duration of mechanical ventilation before enrollment

  1 year

• Total duration of mechanical ventilation

  1 year

• The time before the first SBT

  1 year

Study Arms (2)

PMI-targeted group

EXPERIMENTAL

Will be treated by standard of care for patients undergoing mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.) + pressure support is adjusted according to PMI between 0 and 2 cmH2O during PSV.

Procedure: PMI-targeted PSV setting

VT/RR-targeted group

ACTIVE COMPARATOR

Will be treated by standard of care for patients undergoing mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.).

Procedure: VT/RR-targeted PSV setting

Interventions

PMI-targeted PSV setting PROCEDURE

The pressure support is adjusted according to PMI between 0 and 2 cmH2O. After application of PSV mode in mechanically ventilated patients, the initial PS level was first set based on respiratory rate (RR) \<35 beats/min and 6-8 ml/Kg tidal volume (Vt) per predict body weight (PBW), and then modified according to PMI at a frequency of twice a day (morning and afternoon bedside rounds)# 1) Perform three end- inspiratory occlusions, with at least 1 minute between each measurement, and calculate the mean PMI. 2) Determine whether the PMI is within the target range (0≤PMI≤2cmH2O). 3) If the PMI is not within the target range, adjust the PS level up or down by 1-3 cmH2O and balance for 3-5 minutes. 4) Repeat the above steps until PMI reaches the target. 5) Additional: During PS adjustment, if Vt≤4ml/Kg, respiratory acidosis, respiratory distress, Vt≥8ml/Kg, respiratory alkalosis occurs, return to the safe PS level before adjustment and optimize other treatments.

PMI-targeted group

VT/RR-targeted PSV setting PROCEDURE

Standard of care: the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg PBW and RR between 20 and 35 breaths/min.

VT/RR-targeted group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation;
• Mechanical ventilation expected to be required for at least 24-48 hours 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;
• Presentation with pneumothorax and/or bronchopleural fistula;
• Extracorporeal support;
• Moribund conditions;
• Refusal by the ICU physicians or the patient.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Study Officials

• Jian-Xin Zhou, MD

  Beijing Shijitan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

8610 6392 6666; zhoujx.cn@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start: January 20, 2025
• Primary Completion: March 15, 2025
• Study Completion: April 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)