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Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03025425
Recruitment Status : Terminated (Difficulty in finding suitable patients)
First Posted : January 19, 2017
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Lauri Lehtimäki, 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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Dyspnea Device: Trilogy 100 ® (Philips Respironics) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

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).

Primary Outcome Measures :
  1. Change in dyspnea after initial period of using MPV [ Time Frame: 5-60 min ]

Secondary Outcome Measures :
  1. Change in dyspnea after 24 hours of using MPV [ Time Frame: 24 hours ]
  2. Proportion of subjects having side-effects or not being compliant with MPV [ Time Frame: 24 hours ]
  3. Proportion of subjects gaining from MPV [ Time Frame: 24 hours ]
  4. Proportion of subjects willing to continue on MPV after the intervention [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03025425

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Dpt of Respiratory Medicine, Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Tampere University Hospital
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Principal Investigator: Lauri Lehtimäki, MD Tampere University Hospital, Allergy centre
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Responsible Party: Lauri Lehtimäki, Associate Professor, Tampere University Hospital Identifier: NCT03025425    
Other Study ID Numbers: R16148_TAYS
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory