Clinical trial NCT06108284: Impact of Negative Pressure Ventilation in Patients Hospitalized with Acute Hypercapnic Respiratory Failure
Official title: Impact of Negative Pressure Ventilation in Patients Hospitalized with Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Hayek Medical
First posted: 2023-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of Hypercapnic Respiratory Failure
timeFrame: 1-3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospitals
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Dennis Chairman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.