Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

• Sponsor: Tampere University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03025425
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation; Dyspnea	Device: Trilogy 100 ® (Philips Respironics)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MPV-arm Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.	Device: Trilogy 100 ® (Philips Respironics); Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).

Outcome Measures

Primary Outcome Measures

1. Change in dyspnea after initial period of using MPV [5-60 min]

   Change in dyspnea after initial period of using MPV

Secondary Outcome Measures

1. Change in dyspnea after 24 hours of using MPV [24 hours]

   Change in dyspnea after 24 hours of using MPV

2. 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

3. Proportion of subjects gaining from MPV [24 hours]

   Proportion of subjects gaining from MPV

4. Proportion of subjects willing to continue on MPV after the intervention [24 hours]

   Proportion of subjects willing to continue on MPV after the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dpt of Respiratory Medicine, Tampere University Hospital	Tampere		Finland	33520

Sponsors and Collaborators

• Tampere University Hospital

Investigators

• Principal Investigator: Lauri Lehtimäki, MD, Tampere University Hospital, Allergy centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lauri Lehtimäki, Associate Professor, Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT03025425
• Other Study ID Numbers: R16148_TAYS
• First Posted: Jan 19, 2017
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Dyspnea

Study Results

No Results Posted as of Oct 26, 2021