Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Dyspnea Clinical Trial

Official title:

Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03025425
• Other study ID #: R16148_TAYS
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: October 2021
• 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 acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory 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: 20
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a previous diagnosis of COPD
• hospitalized due to acute exacerbation of COPD
• at least moderate dyspnea (NRS = Numeric Rating Scale = 4)
• no acute hypoventilation (pH = 7.35 and PCO2 = 6.0 kPa)
• able to understand the study and to give informed consent

Exclusion Criteria:

• unable to participate and use MPV due to e.g. delirium or lack of co-operation
• acute hypoventilation (pH < 7.35 or PCO2 > 6.0 kPa)
• acute need for ventilatory support
• the cause of the dyspnea can be successfully treated
• unable to give informed consent
• a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home

Related Conditions & MeSH terms

• COPD Exacerbation
• Dyspnea

Intervention

Device:
• Trilogy 100 ® (Philips Respironics)
Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).

Locations

Country	Name	City	State
Finland	Dpt of Respiratory Medicine, Tampere University Hospital	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 period of using MPV	Change in dyspnea after initial period of using MPV	5-60 min
Secondary	Change in dyspnea after 24 hours of using MPV	Change in dyspnea after 24 hours of using MPV	24 hours
Secondary	Proportion of subjects having side-effects or not being compliant with MPV	Proportion of subjects having side-effects or not being compliant with MPV	24 hours
Secondary	Proportion of subjects gaining from MPV	Proportion of subjects gaining from MPV	24 hours
Secondary	Proportion of subjects willing to continue on MPV after the intervention	Proportion of subjects willing to continue on MPV after the intervention	24 hours