Impact of Negative Pressure Ventilation in Patients Hospitalized with Acute Hypercapnic Respiratory Failure
NCT ID: NCT06108284
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-03
2025-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional Arm
Patients will be placed on Non invasive positive pressure ventilation per current standard of care.
No interventions assigned to this group
Intervention Arm
Patient in this arm will be placed on Biphasic Cuirass Ventilation
Intervention Arm (Biphasic cuirass ventilation)
Patients in this arm will be placed on Biphasic cuirass ventilation
Interventions
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Intervention Arm (Biphasic cuirass ventilation)
Patients in this arm will be placed on Biphasic cuirass ventilation
Eligibility Criteria
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Inclusion Criteria
* pH between 7.20-7.35 in an ABG sample or pH between 7.16-.31 in a venous sample.
Exclusion Criteria
* 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
21 Years
90 Years
ALL
No
Sponsors
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Hayek Medical
UNKNOWN
University of Missouri-Columbia
OTHER
Responsible Party
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Dennis Chairman
Assistant Professor of Clinical Medicine
Principal Investigators
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Dennis Chairman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri Hospitals
Columbia, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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: 10.1016/s0140-6736(00)02323-0.
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.
Other Identifiers
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2094467
Identifier Type: -
Identifier Source: org_study_id
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