Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient

Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis

Cystic Fibrosis, Bronchiectasis, Bacterial, Sputum culture, Orofaringeal swab, Respiratory physiotherapy, Oropharyngeal suction, induced sputum

The goal of this clinical trial is to determine the effectiveness of oropharyngeal suction in detecting microorganisms by comparing it with induced sputum and oropharyngeal swab samples. It also aims to assess the effect of respiratory physiotherapy on improving the results obtained in children aged 5-18 years with chronic lung disease. The main questions it aims to answer are: * What is the diagnostic efficacy of oropharyngeal suction in detecting microorganisms compared with induced sputum? * What is the effect of undergoing a physiotherapy session before sample collection? * How do the results obtained from oropharyngeal suction correlate with those obtained from oropharyngeal swabs? * How does the age of the participants affect the results obtained from each sampling technique and the effect of prior physiotherapy? * Are these techniques safe? Researchers will compare samples collected after a physiotherapy session with those collected without prior physiotherapy to determine whether physiotherapy improves culture results. Participants will be randomized into two groups: one group will undergo a physiotherapy session before sample collection, while the other will not. Three samples will be collected from each participant using oropharyngeal suction, an oropharyngeal swab, and induced sputum. Each participant may take part on multiple occasions, provided that at least one month has elapsed since their previous participation. On each occasion, participants will be randomized again.

Oropharyngeal suction (OPS) is a technique used to obtain respiratory samples from children with chronic respiratory diseases who have difficulty expectorating. However, its diagnostic performance has not been sufficiently compared with that of other sampling techniques commonly used in clinical practice, such as induced sputum (IS) and oropharyngeal swab (OS). Induced sputum is a recommended comparator for evaluating respiratory sampling techniques in patients who have difficulty producing sputum spontaneously. This study will compare the results obtained using OPS with those obtained using IS and OS to assess the agreement between these methods in detecting respiratory microorganisms. In addition, the effect of respiratory physiotherapy prior to sample collection has not been sufficiently investigated in this population. Respiratory physiotherapy promotes the mobilization and clearance of airway secretions and may improve sample quality and increase the detection of respiratory pathogens. This study aims to assess the diagnostic performance of OPS compared with IS and OS and to determine whether respiratory physiotherapy prior to sample collection improves the detection of respiratory microorganisms in children with chronic respiratory diseases. An exploratory analysis will also investigate potential differences between age subgroups (5-11 years and 12-18 years). Study Design This is a randomized, controlled clinical trial with two parallel groups. Participants will be randomized to undergo respiratory physiotherapy before sample collection or to undergo sample collection without prior respiratory physiotherapy. Primary Objective To assess the diagnostic performance of OPS for detecting microorganisms by comparing the results with those obtained from IS, used as the reference comparator. Secondary Objectives To assess the agreement between OPS and OS in detecting respiratory microorganisms; to evaluate whether respiratory physiotherapy prior to sample collection improves microorganism detection; to compare the results obtained using the different sampling techniques; to explore whether the diagnostic performance of the sampling techniques and the effect of respiratory physiotherapy differ between age subgroups (5-11 years and 12-17 years); and to assess the safety and tolerability of the sampling procedures. Study Procedures and Intervention Participants will undergo sample collection using three consecutive sampling procedures: oropharyngeal swab (OS), oropharyngeal suction (OPS), and induced sputum (IS). Participants will be randomized to one of two groups. In the intervention group, a respiratory physiotherapy session will be performed before sample collection. In the control group, samples will be collected without a prior respiratory physiotherapy session. If a participant is unable to expectorate a sputum sample following the induced sputum procedure, oropharyngeal suction will be repeated. In these cases, the sampling sequence will consist of OS, OPS, and a second OPS procedure following induced sputum (OPS\_postIS). All samples will be processed according to standard laboratory protocols. Laboratory personnel responsible for processing and analysing the samples will remain blinded to the intervention allocation. Culture results will be compared across the different sampling techniques, focusing on the presence or absence of microorganisms. Participants may take part in more than one study visit, provided that at least one month has elapsed since their previous participation. Randomization will be performed again at each participation, according to the study protocol. Study Population The study population will consist of children aged 5-18 years with chronic respiratory diseases who require sputum sampling for microbiological culture and are followed by the Paediatric Pulmonology Unit at Hospital Taulí, Sabadell, Spain. Eligible conditions include cystic fibrosis (CF), non-cystic fibrosis bronchiectasis (NCFB), protracted bacterial bronchitis (PBB), and recurrent pneumonia. Statistical Analysis Descriptive statistics will be used to summarize the study data. Quantitative variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be summarized using frequencies and percentages. The diagnostic performance of OPS will be assessed by comparing its culture results with those obtained from IS. Sensitivity, specificity, and positive and negative predictive values will be calculated where appropriate. Agreement between sampling methods will be evaluated using Cohen's kappa coefficient with 95% confidence intervals, using IS as the reference comparator. Exploratory subgroup analyses will investigate potential differences between children aged 5-11 years and those aged 12-18 years. The effect of respiratory physiotherapy on microorganism detection will also be assessed by comparing the results between the randomized groups. The statistical significance level will be set at 0.05. Safety Assessment Adverse events occurring during the sample collection procedures will be recorded to assess the safety and tolerability of the sampling techniques and the respiratory physiotherapy intervention.

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