Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

Overview

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.

Full Title of Study: “Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2020

Interventions

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

Arms, Groups and Cohorts

  • Experimental: MPV-arm
    • Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.

Clinical Trial Outcome Measures

Primary Measures

  • Change in dyspnea after initial period of using MPV
    • Time Frame: 5-60 min
    • Change in dyspnea after initial period of using MPV

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tampere University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lauri Lehtimäki, Associate Professor – Tampere University Hospital
  • Overall Official(s)
    • Lauri Lehtimäki, MD, Principal Investigator, Tampere University Hospital, Allergy centre

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