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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108284
Other study ID # 2094467
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date October 2024

Study information

Verified date February 2024
Source University of Missouri-Columbia
Contact Dennis B Chairman, MD
Phone 573 884 1057
Email chairmand@umsystem.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Intervention Arm (Biphasic cuirass ventilation)
Patients in this arm will be placed on Biphasic cuirass ventilation

Locations

Country Name City State
United States University of Missouri Hospitals Columbia Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Missouri-Columbia Hayek Medical

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dolmage TE, De Rosie JA, Avendano MA, Goldstein RS. Effect of external chest wall oscillation on gas exchange in healthy subjects. Chest. 1995 Feb;107(2):433-9. doi: 10.1378/chest.107.2.433. — View Citation

Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet. 2000 Jun 3;355(9219):1931-5. doi: 10.101 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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