Status:

RECRUITING

A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial

Lead Sponsor:

Capital Medical University

Conditions:

Critical Care

Acute Hypoxic Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

NA

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 inspirat...

Detailed Description

Steering committee (chief investigators): Feng-Xue Zhu, Li Weng, Jian-Xin Zhou Aim. Our aim is to explore clinical and implementation factors relevant to a future definitive randomized controlled tr...

Eligibility Criteria

Inclusion Criteria:

  1. PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation;
  2. Mechanical ventilation expected to be required for at least 24-48 hours 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:

  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. Presentation with pneumothorax and/or bronchopleural fistula;
  7. Extracorporeal support;
  8. Moribund conditions;
  9. Refusal by the ICU physicians or the patient.

Key Trial Info

Start Date :

January 20 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06769360

Start Date

January 20 2025

End Date

April 1 2025

Last Update

February 7 2025

Active Locations (1)

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1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100038