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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: Intervention Arm (Biphasic cuirass ventilation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: eligible patients will be randomized to either the conventional arm (non invasive positive pressure ventilation) vs the intervention arm using the Biphasic Cuirass Ventilation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Arm<br>Patients will be placed on Non invasive positive pressure ventilation per current standard of care. | |
| Active Comparator: Intervention Arm<br>Patient in this arm will be placed on Biphasic Cuirass Ventilation | Device: Intervention Arm (Biphasic cuirass ventilation)<br>* Patients in this arm will be placed on Biphasic cuirass ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Hypercapnic Respiratory Failure | Resolution of Hypercapnic Respiratory failure will be assessed and compared with the current standard of care which is non invasive positive pressure ventilation using Arterial or Venous Blood Gas analysis. | 1-3 days |