Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Not Applicable

Terminated

• Conditions: COPD Exacerbation; Dyspnea
• Interventions: Device: Trilogy 100 ® (Philips Respironics)

• Registration Number: NCT03025425
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MPV-arm	Trilogy 100 ® (Philips Respironics)	Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.

Primary Outcome Measures

Name	Time	Method
Change in dyspnea after initial period of using MPV	5-60 min	Change in dyspnea after initial period of using MPV

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects having side-effects or not being compliant with MPV	24 hours	Proportion of subjects having side-effects or not being compliant with MPV
Change in dyspnea after 24 hours of using MPV	24 hours	Change in dyspnea after 24 hours of using MPV
Proportion of subjects gaining from MPV	24 hours	Proportion of subjects gaining from MPV
Proportion of subjects willing to continue on MPV after the intervention	24 hours	Proportion of subjects willing to continue on MPV after the intervention

Trial Locations

Locations (1)

Dpt of Respiratory Medicine, Tampere University Hospital; 🇫🇮 Tampere, Finland