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Clinical Trials/NCT05902403
NCT05902403
Recruiting
N/A

Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure Based on a Remote Ventilation Monitoring Platform

Peking Union Medical College Hospital4 sites in 1 country400 target enrollmentJune 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mechanical Ventilation Pressure High
Sponsor
Peking Union Medical College Hospital
Enrollment
400
Locations
4
Primary Endpoint
liberation from MV at day 7
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This multicentric prospective clinical practice study aims at evaluating risk factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma and ICU length of stay in patients with elevated initial mean airway pressure based on a remote ventilation monitoring system which records venlitor input and output data (including waveforms).

Detailed Description

Brief Background: Evidence has accumulated that protective lung ventilation and the patient-ventilator interaction are related to the outcome of patients with lung injury. While most current studies focus on the static parameters and their association with outcomes, dynamic ventilation parameters may provide a more comprehensive assessment than static ones. Time-varying features of ventilator parameters should be paid more attention. Recently, we have developed a remote mechanical ventilation visualization network system (RemoteVentilateView) and, simultaneously, a related automatic recognition algorithm for different types of patient-ventilator asynchrony. This system enables ventilation data fully used. Our main focus is on patients who have an average airway pressure no less than 10 cmH2O upon admission to the ICU. This population has a higher ventilation intensity and may be more at risk of ventilator-induce lung injury than the average ICU patients. We aims to identify risks factors associated with a prolonged mechanical ventilation and other outcomes such as barotrauma in this specific population.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients receiving invasive mechanical ventilation, an average mean airway pressure ≥10 cmH2O for 6 consecutive hours within the first 24 hours of ICU admission.

Exclusion Criteria

  • Currently receiving or expected to receive ECMO treatment within 24 hours;
  • Glasgow Coma Scale (GCS) score less than 8 due to cardiac arrest, traumatic brain injury, or acute stroke;
  • Requiring invasive mechanical ventilation due to neuromuscular diseases;
  • Exceeding 24 hours from ICU admission to connection to the remote monitoring system.

Outcomes

Primary Outcomes

liberation from MV at day 7

Time Frame: 7 days

liberation from MV was defined as no need for MV at least 24 consecutive hours.

Secondary Outcomes

  • Duration of mechanical ventilation and 28 days ventilator free days(28 days)
  • Barotrauma(7 days)
  • 28-day Mortality(28 days)

Study Sites (4)

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