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

Last updated: October 21, 2024
Sponsor: University of Missouri-Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Intervention Arm (Biphasic cuirass ventilation)

Clinical Study ID

NCT06108284
2094467
  • Ages 21-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • age <21

  • Pregnant

  • Inmate/Prisoner

  • Contraindication for cuirass ventilator (open chest wound, flail chest, priorthoracic surgery)

  • Chest wall defect, neuromuscular disease or diaphragmatic paralysis.

  • BMI >50

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Intervention Arm (Biphasic cuirass ventilation)
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • University of Missouri Hospitals

    Columbia, Missouri 65212
    United States

    Active - Recruiting

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