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

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06108284

Collaborator

Hayek Medical (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Hypercapnic Respiratory Failure	Device: Intervention Arm (Biphasic cuirass ventilation)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.eligible patients will be randomized to either the conventional arm (non invasive positive pressure ventilation) vs the intervention arm using the Biphasic Cuirass Ventilation.

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional Arm Patients will be placed on Non invasive positive pressure ventilation per current standard of care.
Active Comparator: Intervention Arm Patient in this arm will be placed on Biphasic Cuirass Ventilation	Device: Intervention Arm (Biphasic cuirass ventilation) Patients in this arm will be placed on Biphasic cuirass ventilation

Arm

Intervention/Treatment

No Intervention: Conventional Arm

Patients will be placed on Non invasive positive pressure ventilation per current standard of care.

Active Comparator: Intervention Arm

Patient in this arm will be placed on Biphasic Cuirass Ventilation

Device: Intervention Arm (Biphasic cuirass ventilation)

Patients in this arm will be placed on Biphasic cuirass ventilation

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Missouri Hospitals	Columbia	Missouri	United States	65212

Sponsors and Collaborators

University of Missouri-Columbia
Hayek Medical

Investigators

Principal Investigator: Dennis Chairman, MD, University of Missouri-Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Dennis Chairman, Assistant Professor of Clinical Medicine, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT06108284

Other Study ID Numbers:

2094467

First Posted:

Oct 31, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Respiratory Insufficiency

Hypercapnia

Study Results

No Results Posted as of Nov 3, 2023