Posture, Interface, and Peak Cough Flow (PCF P/I)
Body Posture and Interface Effects on Peak Cough Flow in Healthy Adults: A Randomized Crossover Study
Cough is a key airway protective mechanism requiring coordinated neuromuscular function. Peak cough flow (PCF) is a simple, non-invasive measure widely used to assess cough effectiveness and guide clinical decisions. Current ATS/ERS guidelines recommend measuring PCF in a seated position using a mouthpiece with a nose clip; however, this setup is not always feasible in clinical practice. Some patients cannot maintain posture or ensure an adequate mouthpiece seal, making a facial mask a potential alternative. The influence of body position and interface on PCF measurements remains unclear, with limited evidence from randomized crossover studies.
This study aims to evaluate the effects of body position (sitting vs standing) and measurement interface (mouthpiece vs facial mask) on PCF in healthy young adults. In a randomized within-subject crossover design, participants perform PCF measurements under four conditions (Sit-Mask, Stand-Mask, Sit-Mouthpiece, Stand-Mouthpiece) during a single session. The findings will help inform more flexible and standardized PCF assessment procedures in clinical practice.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Cough is an essential protective mechanism that requires intact neuromuscular function and precise coordination across the inspiratory, compressive, and expulsive phases. Peak cough flow (PCF) is a simple, non-invasive measure, widely used to assess cough intensity and guide clinical decisions. Because of its clinical relevance, standardized procedures are essential. Current ATS/ERS recommendations specify seated testing with a mouthpiece and a noseclip (MP). However, this configuration is not always possible or consistently used in practice. Many patients cannot maintain adequate posture or mouthpiece seal, and a facial mask (FM) may be a feasible alternative. Evidence regarding the effects of posture (sitting vs standing) and interface (MP vs FM) on PCF remains inconsistent, with few studies comparing both factors within the same individuals using a randomized crossover design.
Aims To determine the effects of body position (sitting vs standing) and measurement interface (FM vs MP) on PCF in healthy young adults. We hypothesized that both factors would influence PCF.
Methods This randomized within subject crossover study included healthy, non smoking adults aged 20-30 years. Exclusion criteria were chronic disease, top-level athletic status and any signs of obstruction and/or auscultatory noise (wheezing or stridor) before the trial. Each participant completed four randomized conditions during a single session: Sit-Mask, Stand-Mask, Sit-Mouthpiece, and Stand-Mouthpiece. PCF (L/s) was measured using an ultrasonic spirometer (SpiroScout, Ganshorn). For each condition, participants performed three standardized maneuvers consisting of three tidal breaths, a rapid inspiration to total lung capacity, and a maximal cough; the highest PCF per condition was used for analysis. A two factor repeated measures ANOVA evaluated the effects of posture, interface, and their interaction (α = 0.05).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Brussels, Belgien, 1180
- Cliniques universitaires Saint-Luc
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Healthy adults aged 20 to 30 years
- Non-smoker
- Self-reported good health status
- Able to perform all four randomized cough conditions
Exclusion Criteria:
- Any chronic disease
- Signs of airway obstruction on clinical examination
- Auscultatory abnormalities (wheezing or stridor) prior to testing
- Incomplete participation in all four conditions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Sit-Mask
|
Peak cough flow measured in the seated position.
The facial mask (V2 Mask™, Hans Rudolph, Inc., Kansas, USA; size fitted to participant) was connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter.
Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Peak cough flow measured in the standing position.
Same device and procedure as Sit-Mask condition.
|
|
Aktiv komparator: Stand-Mask
|
Peak cough flow measured in the seated position.
The facial mask (V2 Mask™, Hans Rudolph, Inc., Kansas, USA; size fitted to participant) was connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter.
Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Peak cough flow measured in the standing position.
Same device and procedure as Sit-Mask condition.
|
|
Aktiv komparator: Sit-Mouthpiece
|
Peak cough flow measured in the seated position.
The mouthpiece (Pulmosafe, Lemon Medical GmbH, Hammelburg, Germany) was used with a nose clip and connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter.
Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Peak cough flow measured in the standing position.
Same device and procedure as Sit-Mouthpiece condition.
|
|
Aktiv komparator: Stand-Mouthpiece
|
Peak cough flow measured in the seated position.
The mouthpiece (Pulmosafe, Lemon Medical GmbH, Hammelburg, Germany) was used with a nose clip and connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter.
Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Peak cough flow measured in the standing position.
Same device and procedure as Sit-Mouthpiece condition.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak cough Flow (PCF)
Tidsramme: Day 1
|
PCF measurement in L/s
|
Day 1
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Brennan M, McDonnell MJ, Duignan N, Gargoum F, Rutherford RM. The use of cough peak flow in the assessment of respiratory function in clinical practice- A narrative literature review. Respir Med. 2022 Mar;193:106740. doi: 10.1016/j.rmed.2022.106740. Epub 2022 Jan 15.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2023/14JUI/264
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .