Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease Assessed Using Non-Invasive Electrical Cardiometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212559
• Other study ID #: C107137
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2019
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Negative pressure ventilation (NPV) is a non-invasive ventilation mode which provide better lung expansion. The major complication of NPV is decrease blood pressure and affects the hemodynamics. The effects of NPV on chronic obstructive pulmonary disease (COPD) patients with pulmonary rehabilitation program remains unknown.

Description:

Both of NPV or positive pressure ventilation (PPV) has impact of hemodynamics. NPV with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (CO); In contrast to NPV, the effect of PPV in most situations is a decreased venous return and leads to decreased CO. NPV improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (COPD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with COPD who received pulmonary rehabilitation program with NPV treatment

Exclusion Criteria:

• Recent exacerbation within 3-months

• Existing of tracheostomy

• Absence of NPV used

• Required of oxygen supplement during NPV

• Diagnosed of neuromuscular disease

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Received negative pressure ventilation
Patients who received a negative pressure during inspiratory phase.

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO (cardiac output)	Change of Cardiac output before and after NPV treatment	20 minutes
Primary	SV (stroke volume)	Change of stroke volume before and after NPV treatment	20 minutes
Secondary	SpO2	Change of oxygen saturation before and after NPV treatment	20 minutes
Secondary	RR (respiratory rate)	Change of respiratory rate before and after NPV treatment	20 minutes