Respiratory muscles in end-stage lung disease: what's wrong?

Respiratory Muscles in end-stage lung disease: PAthophysiological Processes & clinical consequences - REspiratory Muscles in end-stage lung disease: pAthophysiological Processes & clinical consequences’ (REMAP)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57881

Enrollment

Registered

2025-04-09

Start date

2025-10-09

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

None

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 years oldSevere COPD defined as COPD GOLD stage III or IV (FEV1 < 50% of predicted; FEV1/FVC ratio < 70%, no significant reversibility, smoking history of at least 10 pack-years).Being on the lung transplant waiting listBeing able to understand the patient information and provide written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Patients suffering from acute conditions at the time of inclusion or LTxPatients using respiratory depressing agents (more than 20 mg of morphine, or an equivalent, or more than 20 mg oxazepam, or an equivalent) at the time of inclusion or LTx 

Design outcomes

Primary

Measure	Time frame
To assess clinical functioning of the respiratory muscles we will assess respiratory electrical activity as a measure of respiratory effort by surface EMG, and thickening fraction of the diaphragm and intercostal muscles and diaphragm excursions by ultrasound and maximal in- and expiratory pressure to assess muscle output; all before and after LTx. We will relate and correct these data for hyperinflation and degree of lung damage by using data from standard care lung function tests and CT scans, and will relate these measurements to prior treatment (NIV settings) and outcome after LTx, by retrieving these data from the EPD. To assess contractility of respiratory myofibers and in vivo respiratory muscle function, biopsies will be taken during LTx surgery and the biopsies will be analyzed in the lab of Prof. Ottenheijm (AmsterdamUMC) for individual myofiber functioning (strength, calcium sensitivity, myofiber characteristics) and in the lab of Dr. Pouwels for extracellular matrix characteristics.	—

Measure

Time frame

To assess clinical functioning of the respiratory muscles we will assess respiratory electrical activity as a measure of respiratory effort by surface EMG, and thickening fraction of the diaphragm and intercostal muscles and diaphragm excursions by ultrasound and maximal in- and expiratory pressure to assess muscle output; all before and after LTx. We will relate and correct these data for hyperinflation and degree of lung damage by using data from standard care lung function tests and CT scans, and will relate these measurements to prior treatment (NIV settings) and outcome after LTx, by retrieving these data from the EPD. To assess contractility of respiratory myofibers and in vivo respiratory muscle function, biopsies will be taken during LTx surgery and the biopsies will be analyzed in the lab of Prof. Ottenheijm (AmsterdamUMC) for individual myofiber functioning (strength, calcium sensitivity, myofiber characteristics) and in the lab of Dr. Pouwels for extracellular matrix characteristics. 

—

Secondary

Measure	Time frame
As this is an exploratory study, all outcomes are regarded as primary	—

Countries

Netherlands

Contacts

Public ContactM.L. Duiverman

Universitair Medisch Centrum Groningen

m.l.duiverman@umcg.nl050-3613200

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)