Palliation of Dyspnea With Mouth Piece Ventilation

NCT ID: NCT03012737

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dyspnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MPV arm

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

Group Type OTHER

Trilogy 100 ® (Philips Respironics)

Intervention Type DEVICE

Trilogy 100 ® (Philips Respironics) on MPV mode.

Interventions

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Trilogy 100 ® (Philips Respironics)

Trilogy 100 ® (Philips Respironics) on MPV mode.

Intervention Type DEVICE

Other Intervention Names

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Mouth piece ventilation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lauri Lehtimäki

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauri Lehtimäki, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Dpt of oncology, Tampere University Hospital

Tampere, , Finland

Site Status

Pirkanmaa Hospice

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 32579086 (View on PubMed)

Other Identifiers

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R16111

Identifier Type: -

Identifier Source: org_study_id

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