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Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Primary Purpose

COPD Exacerbation, Dyspnea

Status

Terminated

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Trilogy 100 ® (Philips Respironics)

About this trial

This is an interventional treatment trial for COPD Exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dpt of Respiratory Medicine, Tampere University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MPV-arm

Arm Description

Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.

Outcomes

Primary Outcome Measures

Change in dyspnea after initial period of using MPV

Secondary Outcome Measures

Change in dyspnea after 24 hours of using MPV

Proportion of subjects having side-effects or not being compliant with MPV

Proportion of subjects gaining from MPV

Proportion of subjects willing to continue on MPV after the intervention

Full Information

NCT ID

NCT03025425

First Posted

January 17, 2017

Last Updated

October 18, 2021

Sponsor

Tampere University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03025425

Brief Title

Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Difficulty in finding suitable patients

Study Start Date

January 2017 (Actual)

Primary Completion Date

August 1, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tampere University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD Exacerbation, Dyspnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MPV-arm

Arm Type

Experimental

Arm Description

Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.

Intervention Type

Device

Intervention Name(s)

Trilogy 100 ® (Philips Respironics)

Intervention Description

Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).

Primary Outcome Measure Information:

Title

Change in dyspnea after initial period of using MPV

Description

Change in dyspnea after initial period of using MPV

Time Frame

5-60 min

Secondary Outcome Measure Information:

Title

Change in dyspnea after 24 hours of using MPV

Description

Change in dyspnea after 24 hours of using MPV

Time Frame

24 hours

Title

Proportion of subjects having side-effects or not being compliant with MPV

Description

Proportion of subjects having side-effects or not being compliant with MPV

Time Frame

24 hours

Title

Proportion of subjects gaining from MPV

Description

Proportion of subjects gaining from MPV

Time Frame

24 hours

Title

Proportion of subjects willing to continue on MPV after the intervention

Description

Proportion of subjects willing to continue on MPV after the intervention

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lauri Lehtimäki, MD

Organizational Affiliation

Tampere University Hospital, Allergy centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dpt of Respiratory Medicine, Tampere University Hospital

City

Tampere

ZIP/Postal Code

33520

Country

Finland

12. IPD Sharing Statement

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Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

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