Hemodynamic Effects of Negative Pressure Ventilation in Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Received negative pressure ventilation

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NPV group; Patients who had treated in pulmonary rehabilitation unit with NPV	Other: Received negative pressure ventilation; Patients who received a negative pressure during inspiratory phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CO (cardiac output)	Change of Cardiac output before and after NPV treatment	20 minutes
SV (stroke volume)	Change of stroke volume before and after NPV treatment	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2	Change of oxygen saturation before and after NPV treatment	20 minutes
RR (respiratory rate)	Change of respiratory rate before and after NPV treatment	20 minutes

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: November 16, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (ACTUAL): December 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: C107137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No