Palliation of Dyspnea With Mouth Piece Ventilation

Dyspnea Clinical Trial

Official title:

Palliation of Dyspnea With Mouth Piece Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03012737
• Other study ID #: R16111
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: October 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Intervention

Device:
• Trilogy 100 ® (Philips Respironics)
Trilogy 100 ® (Philips Respironics) on MPV mode.

Locations

Country	Name	City	State
Finland	Dpt of oncology, Tampere University Hospital	Tampere
Finland	Pirkanmaa Hospice	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dyspnea after initial use of MPV		5 - 60 min
Secondary	Change in dyspnea after 24 hours of using MPV		24 hours
Secondary	Proportion of subjects having side-effects or not being compliant with MPV		24 hours
Secondary	Proportion of subjects gaining from MPV		24 hours
Secondary	Proportion of subjects willing to continue on MPV after the intervention		24 hours