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Posture, Interface, and Peak Cough Flow

NCT07631481 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Peak Cough Flow Measurement

Interventions

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.

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.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2024-08-31
Completion
2026-05-21

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631481 on ClinicalTrials.gov