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

Not Applicable

Recruiting

• Conditions: Acute Hypercapnic Respiratory Failure
• Interventions: Device: Intervention Arm (Biphasic cuirass ventilation)

• Registration Number: NCT06108284
• Lead Sponsor: University of Missouri-Columbia

Brief 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.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-10-31
• Study Start: 2024-04-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Intervention Arm (Biphasic cuirass ventilation)	Patient in this arm will be placed on Biphasic Cuirass Ventilation

Primary Outcome Measures

Name	Time	Method
Resolution of Hypercapnic Respiratory Failure	1-3 days	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.

Trial Locations

Locations (1)

University of Missouri Hospitals; 🇺🇸 Columbia, Missouri, United States