Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

NCT03025425 | Terminated

• 1 other identifier: R16148_TAYS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Change in dyspnea after initial period of using MPV

  Change in dyspnea after initial period of using MPV

  5-60 min

Secondary Outcomes (4)

• Change in dyspnea after 24 hours of using MPV

  24 hours

• Proportion of subjects having side-effects or not being compliant with MPV

  24 hours

• Proportion of subjects gaining from MPV

  24 hours

• Proportion of subjects willing to continue on MPV after the intervention

  24 hours

Study Arms (1)

MPV-arm

EXPERIMENTAL

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

Device: Trilogy 100 ® (Philips Respironics)

Interventions

Trilogy 100 ® (Philips Respironics) DEVICE

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

MPV-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Dpt of Respiratory Medicine, Tampere University Hospital

Tampere, 33520, Finland

Location

Related Publications (1)

• 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.

  PMID: 37155710 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauri Lehtimäki, MD

  Tampere University Hospital, Allergy centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

FI (1)