NCT06108284

Impact of Negative Pressure Ventilation in Patients Hospitalized With Acute Hypercapnic Respiratory Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study aims to find if using a Biphasic Cuirass Ventilation is as effective as using a Non invasive Positive Pressure Ventilation in patients admitted with acute hypercapnic respiratory failure.

Detailed description

Patients presenting via Emergency Room or inpatients who are noted to be in acute hypercapnic respiratory failure will be approached for consent and if they are agreeable will be randomized to the standard of care arm which would be the use of Bilevel Positive pressure ventilation via face mask vs the intervention arm which would use the Biphasic Cuirass Ventilation. Patients will be monitored and treated in the Medical ICU and will be regularly clinically assessed as per usual standard of care. The study investigators will obtain periodic Arterial/Venous Blood gas sampling to assess for improvement or lack thereof in patients Carbon dioxide levels. If patients' condition doesn't improve or deteriorates their primary treating physician will have full authority to withdraw such patients from study and or change the modality of the patient's treatment. This is a pilot study, and the investigators are aiming to compare the success rate of Biphasic cuirass ventilation when compared to non-invasive positive pressure ventilation.

Conditions

• Acute Hypercapnic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Intervention Arm (Biphasic cuirass ventilation)	Patients in this arm will be placed on Biphasic cuirass ventilation

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-06-21
• Completion: 2025-06-21
• First posted: 2023-10-31
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study