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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06108284
Enrollment
50
Registered
2023-10-31
Start date
2024-04-03
Completion date
2025-06-21
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure

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.

Interventions

DEVICEIntervention Arm (Biphasic cuirass ventilation)

Patients in this arm will be placed on Biphasic cuirass ventilation

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER
Hayek Medical
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

can't be done as the two devices are completely different.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of Hypercapnic Respiratory Failure1-3 daysResolution 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDennis Chairman, MD

University of Missouri-Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026