Status:
UNKNOWN
Efficacy and Safety of Automated Closed-loop Ventilator vs Conventional Open-loop Ventilator in the Emergency Department
Lead Sponsor:
University of Malaya
Conditions:
Ventilator Lung
Mechanical Ventilation Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients presenting to the emergency department (ED) may require breathing support with machines depending on the condition. Throughout the breathing support, the settings on the breathing machines wi...
Detailed Description
Invasive mechanical ventilation is a lifesaving intervention for patients with respiratory failure in the emergency department (ED). Recent technological advancements have introduced closed-loop autom...
Eligibility Criteria
Inclusion
- Decision made by treating physicians to intubate and mechanically ventilate
Exclusion
- Suspected or confirmed pregnancy.
- Known right ventricular heart failure upon assessment for recruitment.
- Severe metabolic acidosis upon intubation (pH \<7.2 or bicarbonate \<12 mmol/L)
- Circulatory shock requiring noradrenaline more than 0.5 mcg/kg/min upon assessment for recruitment.
- Severe or acute life-threatening asthma.
- Patients with chest wall deformities that would affect ventilation (e.g. severe kyphoscoliosis, diaphragmatic hernia, flail chest, trauma, pectus excavatum or carinatum, ankylosing spondylitis
- Patients with previous lobectomy or pneumonectomy.
- Patients with pneumothorax or other condition that requires chest drainage tube.
- Patients with body mass index \> 40 kg/m2.
- Manufacturer's contraindications:
- Difference in oxygen saturation between pulse oximetry (SpO2) and arterial sample (SaO2) of more than 5% (due to unreliable sensor).
- Difference in carbon dioxide level between end-tidal sensor (ETCO2) and arterial sample (PaCO2) of more than 5 mm Hg (due to unreliable sensor).
- Known pneumothorax and bronchopulmonary fistula upon assessment for recruitment.
- Participation in another interventional trial.
- Do-not-attempt-resuscitation (DNAR) order.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06157073
Start Date
January 1 2024
End Date
December 31 2025
Last Update
December 5 2023
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