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

Acute Hypercapnic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108284
• Other study ID #: 2094467
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: University of Missouri-Columbia
• Contact: Dennis B Chairman, MD
• Phone: 573 884 1057
• Email: chairmand[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• Intervention Arm (Biphasic cuirass ventilation)
Patients in this arm will be placed on Biphasic cuirass ventilation

Locations

Country	Name	City	State
United States	University of Missouri Hospitals	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Hayek Medical

Country where clinical trial is conducted

United States, 

References & 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. — View 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: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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