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

NCT ID: NCT06108284

Last Updated: 2024-10-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Acute Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Conventional Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Patient in this arm will be placed on Biphasic Cuirass Ventilation

Group Type ACTIVE_COMPARATOR

Intervention Arm (Biphasic cuirass ventilation)

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hayek Medical

UNKNOWN

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Dennis Chairman

Assistant Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dennis B Chairman, MD

Role: CONTACT

573 884 1057

Armin Krvavac, MD

Role: CONTACT

573 884 0808

Facility Contacts

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Dennis Chairman, MD

Role: primary

573 884 1057

Armin Krvavac, MD

Role: backup

573 884 0808

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.

Reference Type BACKGROUND
PMID: 10859037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7842774 (View on PubMed)

Other Identifiers

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2094467

Identifier Type: -

Identifier Source: org_study_id

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