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

NCT06108284 | Terminated DMC FDA Device

• 1 other identifier: 2094467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional Arm

NO INTERVENTION

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

Intervention Arm

ACTIVE COMPARATOR

Patient in this arm will be placed on Biphasic Cuirass Ventilation

Device: Intervention Arm (Biphasic cuirass ventilation)

Interventions

Intervention Arm (Biphasic cuirass ventilation) DEVICE

Patients in this arm will be placed on Biphasic cuirass ventilation

Intervention Arm

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Hayek Medical: collaborator

Study Sites (1)

University of Missouri Hospitals

Columbia, Missouri, 65212, United States

Location

Related 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.

  PMID: 7842774 BACKGROUND

• 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.

  PMID: 10859037 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Dennis Chairman, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: can't be done as the two devices are completely different.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

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

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 31, 2023
• Study Start: April 3, 2024
• Primary Completion: June 21, 2025
• Study Completion: June 21, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)