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

University of Missouri (MU)

Status: Enrolling

Conditions: Acute Hypercapnic Respiratory Failure

Treatments: Device: Intervention Arm (Biphasic cuirass ventilation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06108284

2094467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• admission diagnosis of hypercapnic respiratory failure
• pH between 7.20-7.35 in an ABG sample or pH between 7.16-.31 in a venous sample.

Exclusion criteria

• age <21
• Pregnant
• Inmate/Prisoner
• Contraindication for cuirass ventilator (open chest wound, flail chest, prior thoracic surgery)
• Chest wall defect, neuromuscular disease or diaphragmatic paralysis.
• BMI >50

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Conventional Arm

No Intervention group

Description:

Patients will be placed on Non invasive positive pressure ventilation per current standard of care.

Intervention Arm

Active Comparator group

Description:

Patient in this arm will be placed on Biphasic Cuirass Ventilation

Treatment:

Device: Intervention Arm (Biphasic cuirass ventilation)