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Palliation of Dyspnea With Mouth Piece Ventilation

Sponsor
Tampere University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03012737
Collaborator
(none)
22
Enrollment
2
Locations
1
Arm
35
Actual Duration (Months)
11
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Trilogy 100 ® (Philips Respironics)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Palliation of Dyspnea With Mouth Piece Ventilation
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in dyspnea after initial use of MPV [5 - 60 min]

    Secondary Outcome Measures

    1. Change in dyspnea after 24 hours of using MPV [24 hours]

    2. Proportion of subjects having side-effects or not being compliant with MPV [24 hours]

    3. Proportion of subjects gaining from MPV [24 hours]

    4. Proportion of subjects willing to continue on MPV after the intervention [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dpt of oncology, Tampere University Hospital Tampere Finland 33520
    2 Pirkanmaa Hospice Tampere Finland 33520

    Sponsors and Collaborators

    • Tampere University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lauri Lehtimäki, Associate professor, Tampere University Hospital
    ClinicalTrials.gov Identifier:
    NCT03012737
    Other Study ID Numbers:
    • R16111
    First Posted:
    Jan 6, 2017
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Dyspnea

    Study Results

    No Results Posted as of Oct 8, 2020