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Does the result of a LEOSound® lung sound recorder correlate to the FEES for the detection of aspirations in patients with neurogenic dysphagia? - A Pilot-Study

Does the result of a LEOSound® lung sound recorder correlate to the FEES for the detection of aspirations in patients with neurogenic dysphagia? - A Pilot-Study - Predictive value of a LEOSound® lung sound recorder in detection of aspirations: a pilot-study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025011
Enrollment
30
Registered
2021-04-09
Start date
2020-02-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

I60-I69

Interventions

Group 1: Non-interventional, prospective, observational cohort study All patients will undergo a standard dysphagia diagnostic procedures for post stroke dysphagia. In the first step all enrolled pat

Sponsors

Zürcher RehaZentren Wald
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are: - age between 18-85 years, - First stroke - Suspected neurogenic swallowing disorders up to 6 weeks post onset.

Exclusion criteria

Exclusion criteria: We exclude patients with: - Presence of a neurological condition other than stroke, which can lead to dysphagia; - already known history of swallowing difficulties due to previous strokes, - all other diseases that correlate with an increased risk of coughing during the night measurement (i.e. COPD, asthma), - Lung infection, - acute infection, - require invasive or non-invasive ventilation, - physical or cognitive impairments that lead to a limitation in the performance of the planned diagnostics (i.e. restlessness), - be discharged before the diagnosis could be completed

Design outcomes

Primary

MeasureTime frame
The purpose of this pilot study is to investigate whether an increased cough measured with LEOSound® in stroke patients during the night correlates with the rate of pneumonia. We will perform instrumental diagnosis of dysphagia using fiber endoscopic assessment of swallowing (FEES) based on Langmore's recommendations. We will rate the severity of penetration or aspiration on the Rosenbeks Penetration-Aspiration Scale (PAS), which records the highest PAS score of all consistencies tested. We have classified the results as follows: (1) PAS I-II: normal-mild (no aspiration, penetration with clearing), (2) PAS III-V: moderate (penetrations), (3) PAS VI-VIII: severe (aspirations), whereby: (4) PAS VIII is defined as silent aspiration. Then an 8-hour recording of the nocturnal cough frequency is carried out with the LEOSound® system for FEES patients. After the recordings have been completed, they are automatically analyzed by the LEOSound-Analyzer® software, which automatically evaluates the data for breathing sounds such as wheezing, coughing and breathing rate and saves the results and raw data in a database. The analysis delivers the HCR values ??(hourly cough rate) and HCEC values ??(hourly cough events, categorized). The occurrence of pneumonia during the neurorehabilitation stay is taken from the patient's file on the day of discharge. A diagnosis of pneumonia according to the guidelines is considered given if all of the following events occur: (1) New lung infiltrates on breast imaging (2) Respiratory arrest (3) fever (4) Productive cough. Stepwise multiple regression is used to select explanatory variables that offer the best predictors of pneumonia in the model construction phase. Ultimately, two predictor variables are used to build regression models that predict Y pneumonia. The significance level for all analyzes is set to p = 0.05.

Secondary

MeasureTime frame
In addition, it is examined whether there are associations between the results of the cough monitoring and the evaluations according to the instrumental swallowing diagnostics using FEES. The following hypotheses were made: 1) The lack of or low nocturnal cough frequency in patients with a clinically high risk of aspiration may indicate a disorder of the reflex cough as a protective mechanism leading to pneumonia. 2) A high frequency of nocturnal coughing in patients with a clinically normal swallowing process may indicate microaspiration that is clinically undetectable. We will perform instrumental diagnosis of dysphagia using fiber endoscopic assessment of swallowing (FEES) based on Langmore's recommendations. We will rate the severity of penetration or aspiration on the Rosenbeks Penetration-Aspiration Scale (PAS), which records the highest PAS score of all consistencies tested. We have classified the results as follows: (1) PAS I-II: normal-mild (no aspiration, penetration with clearing), (2) PAS III-V: moderate (penetrations), (3) PAS VI-VIII: severe (aspirations), whereby: (4) PAS VIII is defined as silent aspiration. We will assess the accumulation of secretion using the Murrays Rating of the Secretion Scale (ROS), with the results classified as follows: (1) ROS 0: normal rating, (2) ROS 1: all secretions that are recognizable when entering the protective structures surrounding the larynx and that are shown bilaterally or pooled deeply; (3) ROS 2: all secretions that change from "1" to "3" during the observation period, (4) ROS 3: all secretions seen in the area defined as the larynx vestibule that contains pulmonary secretions if not cleared by swallowing or coughing at the end of the segment. We will evaluate respiratory protection using the Murray pattern of respiratory arrest (PTBH) and classify it as follows: (1) PTBH 1: respiratory arrest not reached, (2) PTBH 2: Temporary respiratory arrest with open glottis, (3) PTBH 3: Holding breath with open glo

Countries

Switzerland

Contacts

Public ContactAnna Maria Pekacka-Egli

ZRZ Klinik Wald

annamaria.pekacka@zhreha.ch0041552566970

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026