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Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

NCT ID: NCT03025425

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-08-01

Brief Summary

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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

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Conditions

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COPD Exacerbation Dyspnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MPV-arm

Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.

Group Type EXPERIMENTAL

Trilogy 100 ® (Philips Respironics)

Intervention Type DEVICE

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

Interventions

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Trilogy 100 ® (Philips Respironics)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lauri Lehtimäki

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauri Lehtimäki, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital, Allergy centre

Locations

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Dpt of Respiratory Medicine, Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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Leivo-Korpela S, Rantala HA, Piili RP, Lehtimaki L, Lehto JT. Palliation of Dyspnea With Mouthpiece Ventilation in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Feasibility Study. J Palliat Med. 2023 Sep;26(9):1261-1265. doi: 10.1089/jpm.2023.0039. Epub 2023 May 4.

Reference Type DERIVED
PMID: 37155710 (View on PubMed)

Other Identifiers

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R16148_TAYS

Identifier Type: -

Identifier Source: org_study_id