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Palliation of Dyspnea With Mouth Piece Ventilation

Primary Purpose

Dyspnea

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Trilogy 100 ® (Philips Respironics)
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspnea

Eligibility Criteria

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

Inclusion Criteria:

  • at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
  • incurable advanced disease
  • able to understand the study and to give informed consent
  • would not gain from intensive care or resuscitation according to the treating physician

Exclusion Criteria:

  • unable to participate and use MPV due to e.g. delirium or lack of co-operation
  • the cause of the dyspnea can be succesfully treated
  • unable to give informed consent

Sites / Locations

  • Dpt of oncology, Tampere University Hospital
  • Pirkanmaa Hospice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MPV arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in dyspnea after initial use of 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

First Posted
January 5, 2017
Last Updated
October 6, 2020
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03012737
Brief Title
Palliation of Dyspnea With Mouth Piece Ventilation
Official Title
Palliation of Dyspnea With Mouth Piece Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in finding suitable patients.
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and from oncology 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
Dyspnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MPV arm
Arm Type
Other
Arm Description
Subjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours.
Intervention Type
Device
Intervention Name(s)
Trilogy 100 ® (Philips Respironics)
Other Intervention Name(s)
Mouth piece ventilation
Intervention Description
Trilogy 100 ® (Philips Respironics) on MPV mode.
Primary Outcome Measure Information:
Title
Change in dyspnea after initial use of MPV
Time Frame
5 - 60 min
Secondary Outcome Measure Information:
Title
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
Time Frame
24 hours
Title
Proportion of subjects gaining from MPV
Time Frame
24 hours
Title
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
No
Eligibility Criteria
Inclusion Criteria: at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4) incurable advanced disease able to understand the study and to give informed consent would not gain from intensive care or resuscitation according to the treating physician Exclusion Criteria: unable to participate and use MPV due to e.g. delirium or lack of co-operation the cause of the dyspnea can be succesfully treated unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauri Lehtimäki, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of oncology, Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pirkanmaa Hospice
City
Tampere
ZIP/Postal Code
33520
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32579086
Citation
Lehto JT, Leivo-Korpela S, Korhonen T, Rantala HA, Raunio H, Lyly-Yrjanainen T, Lehtimaki L. Mouthpiece ventilation in the management of dyspnea: A single-arm pilot study. Palliat Med. 2020 Oct;34(9):1274-1278. doi: 10.1177/0269216320935003. Epub 2020 Jun 24.
Results Reference
derived

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Palliation of Dyspnea With Mouth Piece Ventilation

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