1. The aim of this study is to determine the minimal clinically relevant differences in impulse oscillometry2. To evaluate whether patients find the IOS measurements more comfortable compared to traditional methods.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Spirometrie parameter:
o Forced vital capacity (FVC)
o Forced expiratory volume in 1s (FEV1)
• Difusing capacity of carbondioxide (DLCO)
• Multiple FOT-parameters:
o Respiratory reactance (X5) --> retraction capacity + degree of peripheral
obstruction
o Respiratory resistance (R5) --> total respiratory resistance (large airways +
small airways + extrathoracic airways like the oropharynx and larynx)
o Respiratory resistance (R5) 20-15 Hz (Rrs20-5) --> small airways index
• RAND-36
• 5-point Likert-scale
Secondary outcome
Questionnaires
Patient Evaluation Form:
- VAS Cough: A visual analog scale (VAS) to assess the intensity of coughing
experienced by the patient during the procedure.
- VAS Shortness of Breath: A VAS to measure the severity of breathlessness
during the procedure.
- VAS Comfort: A VAS to evaluate the overall comfort level of the patient
during the test.
- General Procedure Feedback: Open-ended section for patients to provide
feedback on the procedure, including any suggestions or issues encountered.
- Quality of life questionnaires (RAND-36 & L-PF)
Staff Evaluation Form:
Procedure Duration: Record the total time taken to complete the procedure.
Was it possible to perform the lung function and/or FOT measurement?
No: Provide a reason for the failure to complete the measurement:
- Coughing
- Shortness of breath
- Fatigue/Low energy
Yes:
- Assess the Quality of the Measurement: Rate on a scale: poor - moderate -
adequate - good.
- Number of Attempts: Document how many attempts were required to obtain a
usable measurement.
- Variation Between Measurements: Record any inconsistencies or variability
across repeated measurements.
- Medical Conclusion Based on the Results: Provide a clinical interpretation of
the results, considering the quality and reliability of the data obtained.
Background summary
The term interstitial lung diseases (ILDs) refers to a collective group of over
one hundred distinct pulmonary conditions. All of these diseases involve the
"interstitium," which is the space between the alveoli and blood vessels.
Examples of ILDs include sarcoidosis, pulmonary fibrosis, alveolar proteinosis,
and extrinsic allergic alveolitis.
This study primarily focuses on patients with pulmonary fibrosis. Pulmonary
fibrosis is characterized by scarring of the lung tissue, leading to
progressive shortness of breath, reduced lung function, and a poor prognosis.
In idiopathic pulmonary fibrosis (IPF), the median survival is 2-3 years after
diagnosis. At diagnosis, lung diffusion capacity is often reduced by 50%, and
spirometry measurements typically indicate a restrictive pattern. Regular
follow-up of lung function is crucial for assessing treatment efficacy, disease
progression, and predicting the clinical course. IPF patients are generally
monitored every 3-6 months with lung function tests. These tests require deep
inhalations, which can provoke coughing episodes and be particularly
challenging for patients already experiencing significant breathlessness.
Forced Oscillation Technique (FOT) may offer a suitable alternative lung
function test for this patient population. FOT uses sound waves to measure the
mechanical properties of the lungs during normal breathing. These sound waves
are perceived as vibrations. By employing sound waves of different frequencies,
IOS can assess resistance in both the large airways (high frequencies), as well
as the small and peripheral airways (low frequencies). IOS is already used in
other hospitals for pulmonary studies in children, intensive care patients, and
in conditions such as COPD and asthma. Although there have been a limited
number of studies on IOS measurements in pulmonary fibrosis patients, these
studies suggest that IOS may offer advantages over traditional lung function
tests. However, no long-term follow-up studies have yet demonstrated that IOS
can effectively track disease progression over time. Therefore, this study aims
to investigate whether IOS is suitable for monitoring disease progression and
treatment effects in the long term.
Study objective
1. The aim of this study is to determine the minimal clinically relevant
differences in impulse oscillometry
2. To evaluate whether patients find the IOS measurements more comfortable
compared to traditional methods.
Study design
The study will be a prospective cohort study conducted at the ILD Centre of
Excellence at St. Antonius Hospital in Nieuwegein. Participants will visit the
hospital as per their routine care schedule. Patients with pulmonary fibrosis
who are scheduled for at least one lung function test or a high-resolution CT
(HRCT) scan will be screened and approached for participation in this study. In
addition to their standard tests, they will undergo an FOT (Forced Oscillation
Technique) measurement. These measurements will be repeated during hospital
visits to monitor disease progression. Patients enrolled in the study will be
followed until the study's conclusion, for a maximum of 3 years.
Study burden and risks
The burden and risk of the research is considered negligible
koekoekslaan 1
Nieuwegeijn 3435 CM
NL
koekoekslaan 1
Nieuwegeijn 3435 CM
NL
Listed location countries
Age
Inclusion criteria
patients with pulmonary fibrosis
aged 18 years and older
Exclusion criteria
pregnancy
breast feeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88080.100.24 |