Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency

An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.

Study Overview

• Status: Terminated
• Conditions: COPD Exacerbation; Dyspnea
• Intervention / Treatment: Device: Trilogy 100 ® (Philips Respironics)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Dpt of Respiratory Medicine, Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• a previous diagnosis of COPD
• hospitalized due to acute exacerbation of COPD
• at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
• no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)
• able to understand the study and to give informed consent

Exclusion Criteria:

• unable to participate and use MPV due to e.g. delirium or lack of co-operation
• acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa)
• acute need for ventilatory support
• the cause of the dyspnea can be successfully treated
• unable to give informed consent
• a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MPV-arm; Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.	Device: Trilogy 100 ® (Philips Respironics); Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dyspnea after initial period of using MPV	Change in dyspnea after initial period of using MPV	5-60 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dyspnea after 24 hours of using MPV	Change in dyspnea after 24 hours of using MPV	24 hours
Proportion of subjects having side-effects or not being compliant with MPV	Proportion of subjects having side-effects or not being compliant with MPV	24 hours
Proportion of subjects gaining from MPV	Proportion of subjects gaining from MPV	24 hours
Proportion of subjects willing to continue on MPV after the intervention	Proportion of subjects willing to continue on MPV after the intervention	24 hours

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Principal Investigator: Lauri Lehtimäki, MD, Tampere University Hospital, Allergy Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: R16148_TAYS