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Risk Factors for Prolonged Mechanical Ventilation in Elevated Mean Airway Pressure

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05902403
Enrollment
400
Registered
2023-06-15
Start date
2023-06-01
Completion date
2024-06-01
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit, Mechanical Ventilation Pressure High

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.

Interventions

OTHERinvasive mechanical ventilation

Invasive mechanical ventilation for patients admitted to the ICU

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
liberation from MV at day 77 daysliberation from MV was defined as no need for MV at least 24 consecutive hours.

Secondary

MeasureTime frameDescription
Duration of mechanical ventilation and 28 days ventilator free days28 daysVentilator-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.
Barotrauma7 daysWe 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.
28-day Mortality28 days

Countries

China

Contacts

Primary ContactYun Long, Dr
ly_icu@aliyun.com010-69152300
Backup ContactLongxiang Su, Dr
slx77@163.com010-69152301

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026