Study Stopped
Difficulty in finding suitable patients.
Palliation of Dyspnea With Mouth Piece Ventilation
1 other identifier
interventional
22
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 5, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 8, 2020
October 1, 2020
2.9 years
January 5, 2017
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in dyspnea after initial use of MPV
5 - 60 min
Secondary Outcomes (4)
Change in dyspnea after 24 hours of using MPV
24 hours
Proportion of subjects having side-effects or not being compliant with MPV
24 hours
Proportion of subjects gaining from MPV
24 hours
Proportion of subjects willing to continue on MPV after the intervention
24 hours
Study Arms (1)
MPV arm
OTHERSubjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours.
Interventions
Trilogy 100 ® (Philips Respironics) on MPV mode.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dpt of oncology, Tampere University Hospital
Tampere, 33520, Finland
Pirkanmaa Hospice
Tampere, 33520, Finland
Related Publications (1)
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.
PMID: 32579086DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauri Lehtimäki, MD
Tampere University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
January 5, 2017
First Posted
January 6, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share