An interventional study of Respiratory physiothperapy and Oropharyngeal suction in Cystic Fibrosis (CF) and Bronchiectasis, Non-Cystic Fibrosis, sponsored by Corporacion Parc Tauli. Recruiting at 1 site in Spain. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Diagnostic
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:
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.
1,609 studies on the registry are indexed under Cystic Fibrosis; 197 are open to participants now.
This study's planned enrollment of 196 is above the median of 36 across 1,052 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Corporacion Parc Tauli is the lead sponsor of 167 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Participants will undergo a physiotherapy session before sample collection, consisting of inspiratory exercises and airway clearance techniques. Following the session, three samples will be collected: oropharyngeal swap, oropharyngeal suction, and induced sputum.
Other: Respiratory physiothperapy · Other: Oropharyngeal suction · Other: Oropharyngeal swab · Other: Induced Sputum
Three samples will be collected: oropharyngeal swab, oropharyngeal suction, and induced sputum.
Other: Oropharyngeal suction · Other: Oropharyngeal swab · Other: Induced Sputum
It has not been studied whether carrying out a respiratory physiotherapy session prior to sampling improves the diagnostic performance of the different methods.
Sterile aspiration of the oropharyngeal area to collect mucus.
Sterile swab of the oropharyngeal area to collect mucus.
Collection of expectorated sputum after a 15-minute nebulization with a 4.5% hypertonic saline solution
Presence/absence of microorganisms in each sample, as a binary variable
To determine the diagnostic efficacy of oropharyngeal suction, the detection of the studied microorganisms in the samples obtained using this method will be evaluated as a binary variable (presence/absence). The microorganisms studied are: * Staphylococcus aureus, methicillin-sensitive (MSSA) and methicillin-resistant (MRSA) * Pseudomonas aeruginosa (PA) * Haemophilus influenzae (HI) * Streptococcus pneumoniae (SP) * Enterobacter cloacae (EC) * Burkholderia cepacia (BC) * Moraxella catarrhalis (MC) * Mycobacterium abscessus (MA) * Aspergillus fumigatus (AF) * Other From these variables, the following derived indicators will be obtained: * Suction vs. induced sputum agreement (percentage agreement and kappa coefficient) * Suction sensitivity * Suction specificity
Time frame: At baseline
Presence/absence of microorganisms in Oropharyngeal Suction and Induced Sputum obtained post-physiotherapy
To determine the effect of a physiotherapy session prior to sample collection, the presence/absence of the studied microorganisms in samples obtained by suction and those obtained through induced sputum will be evaluated. The following derived indicators will be compared with those of the group that has NOT undergone prior physiotherapy to determine whether this improves the agreement between the methods: * Suction and induced sputum agreement by group (κ and % agreement) * Sensitivity and specificity stratified by group
Time frame: At baseline
Presence/absence of microorganisms in oropharyngeal swab and oropharyngeal suction
To compare the results obtained from samples collected by oropharyngeal swab and those obtained by oropharyngeal suction, the presence or absence of the microorganisms studied will be determined in both samples. The degree of agreement will be calculated as a derived indicator (κ and percentage of agreement).
Time frame: At baseline
Sensitivity and specificity of oropharyngeal suction and oropharyngeal swab compared to induced sputum
It will be determined by the proportions of true positives and true negatives, respectively, relative to induced sputum, which is considered the reference method.
Time frame: At baseline
Age
Quantitative variable (years), which will be categorized into two subgroups for analysis: children (5-11 years) and adolescents (12-18 years). It will be used as a potential effect modifier in the analysis of diagnostic concordance and response to respiratory physiotherapy.
Time frame: At baseline
Oxygen saturation
Oxygen saturation (as a percentage) to determine safety of the three sample taking methods.
Time frame: Before and immediately after the procedure
Heart rate
Heart rate (in beats per minute) will be recorded before and after sample collection to determine the safety of each technique.
Time frame: Before and immediately after the procedure
Presence/absence of adverse effects
The presence or absence of the following adverse effects will be recorded both during sample collection and on the following day: * Irritative/persistent cough * Vomiting * Nausea * Other (specify)
Time frame: During the procedure and up to 24 hours post-procedure.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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