Efficacy and Safety of Automated Closed-loop Ventilator vs Conventional Open-loop Ventilator in the Emergency Department

Launched by UNIVERSITY OF MALAYA · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two types of breathing machines used in the emergency department: conventional ventilators, which require doctors to manually adjust settings, and automated closed-loop ventilators, which can automatically change their settings based on the patient's needs. The goal is to see which machine provides better care by ensuring patients get the right levels of oxygen and carbon dioxide while on the ventilator. This research could help improve treatment for patients who are having trouble breathing due to serious conditions like lung injury or respiratory distress.

To be eligible for this trial, participants must be adults who need to be intubated and placed on a ventilator as decided by their doctors. However, certain patients are excluded, such as those who are pregnant, have severe heart or lung conditions, or are significantly overweight. Participants will receive careful monitoring during the study, and their well-being will be a top priority. The findings from this research could lead to better and safer breathing support for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Decision made by treating physicians to intubate and mechanically ventilate
• Exclusion Criteria:
• • 1. Suspected or confirmed pregnancy.
• • 2. Known right ventricular heart failure upon assessment for recruitment.
• • 3. Severe metabolic acidosis upon intubation (pH \<7.2 or bicarbonate \<12 mmol/L)
• • 4. Circulatory shock requiring noradrenaline more than 0.5 mcg/kg/min upon assessment for recruitment.
• • 5. Severe or acute life-threatening asthma.
• • 6. Patients with chest wall deformities that would affect ventilation (e.g. severe kyphoscoliosis, diaphragmatic hernia, flail chest, trauma, pectus excavatum or carinatum, ankylosing spondylitis
• • 7. Patients with previous lobectomy or pneumonectomy.
• • 8. Patients with pneumothorax or other condition that requires chest drainage tube.
• • 9. Patients with body mass index \> 40 kg/m2.
• 10. 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.
• • 11. Participation in another interventional trial.
• • 12. Do-not-attempt-resuscitation (DNAR) order.