Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure
- Conditions
- Mechanical Ventilation Pressure HighIntensive Care Unit
- Interventions
- Other: invasive mechanical ventilation
- Registration Number
- NCT05902403
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Patients receiving invasive mechanical ventilation, an average mean airway pressure ≥10 cmH2O for 6 consecutive hours within the first 24 hours of ICU admission.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elevated Initial Mean Airway Pressure invasive mechanical ventilation Patients recieving invasive mechanical ventilation with mean airway pressure no less than 10 centimeter of water within the first 24 hours on ICU admission.
- Primary Outcome Measures
Name Time Method liberation from MV at day 7 7 days liberation from MV was defined as no need for MV at least 24 consecutive hours.
- Secondary Outcome Measures
Name Time Method 28-day Mortality 28 days Duration of mechanical ventilation and 28 days ventilator free days 28 days Ventilator-free days (VFDs) were defined as a time frame of 28 days from intubation. For intubated patients, in caseof reintubation within 28 days, VFDs were counted from the last successful extubation. The use of non-invasive ventilation (NIV) after extubation was not considered as a ventilation period. Finally, zero VFDs were assigned to 28-day non-survivors, regardless of their intubation status.
Barotrauma 7 days We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele \> 2cm detected on image exams between inclusion and 7 days, except those judged to be clearly caused by invasive procedures.
Trial Locations
- Locations (4)
Peking Union Medical College Hospital
🇨🇳Peking, Beijing, China
Qilu Hospital of Shangdong University
🇨🇳Jinan, Shandong, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, China