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.

Study Overview

• Status: Completed
• Conditions: Peak Cough Flow Measurement
• Intervention / Treatment: Device: Facial mask (V2 Mask™, Hans Rudolph); Device: Facial mask (V2 Mask™, Hans Rudolph); Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip; Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1180
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sit-Mask	Device: Facial mask (V2 Mask™, Hans Rudolph); 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.; Device: Facial mask (V2 Mask™, Hans Rudolph); Peak cough flow measured in the standing position. Same device and procedure as Sit-Mask condition.
Active Comparator: Stand-Mask	Device: Facial mask (V2 Mask™, Hans Rudolph); 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.; Device: Facial mask (V2 Mask™, Hans Rudolph); Peak cough flow measured in the standing position. Same device and procedure as Sit-Mask condition.
Active Comparator: Sit-Mouthpiece	Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip; 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.; Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip; Peak cough flow measured in the standing position. Same device and procedure as Sit-Mouthpiece condition.
Active Comparator: Stand-Mouthpiece	Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip; 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.; Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip; Peak cough flow measured in the standing position. Same device and procedure as Sit-Mouthpiece condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak cough Flow (PCF)	PCF measurement in L/s	Day 1

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): May 21, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cough; peak cough flow; interfaces; postures
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cough
• Other Study ID Numbers: 2023/14JUI/264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No