Palliation of Dyspnea With Mouth Piece Ventilation

October 6, 2020 updated by: Lauri Lehtimäki, Tampere University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33520
        • Dpt of oncology, Tampere University Hospital
      • Tampere, Finland, 33520
        • Pirkanmaa Hospice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MPV arm
Subjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours.
Device: Trilogy 100 ® (Philips Respironics)
Trilogy 100 ® (Philips Respironics) on MPV mode.
Other Names:
  • Mouth piece ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in dyspnea after initial use of MPV
Time Frame: 5 - 60 min
5 - 60 min

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Lauri Lehtimäki, MD, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R16111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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