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Palliation of Dyspnea With Mouth Piece Ventilation

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ClinicalTrials.gov Identifier: NCT03012737
Recruitment Status : Terminated (Difficulty in finding suitable patients.)
First Posted : January 6, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Lauri Lehtimäki, Tampere University Hospital

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
Dyspnea Device: Trilogy 100 ® (Philips Respironics) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Mouth piece ventilation




Primary Outcome Measures :
  1. Change in dyspnea after initial use of MPV [ Time Frame: 5 - 60 min ]

Secondary Outcome Measures :
  1. Change in dyspnea after 24 hours of using MPV [ Time Frame: 24 hours ]
  2. Proportion of subjects having side-effects or not being compliant with MPV [ Time Frame: 24 hours ]
  3. Proportion of subjects gaining from MPV [ Time Frame: 24 hours ]
  4. Proportion of subjects willing to continue on MPV after the intervention [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012737


Locations
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Finland
Dpt of oncology, Tampere University Hospital
Tampere, Finland, 33520
Pirkanmaa Hospice
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Lauri Lehtimäki, MD Tampere University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lauri Lehtimäki, Associate professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03012737    
Other Study ID Numbers: R16111
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory