Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial

BackgroundOropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. MethodsWe plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of ‘CFE + CA’ versus ‘CFE’ only compared to MBS-identified OPA. DiscussionEarly detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility of CA in assessing and diagnosing OPA risk in young children

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Acoustic and perceptual profiles of swallowing sounds in children: Normative data for 4-36 months from a cross-sectional study cohort

Limited data on cervical auscultation (CA) sounds during the transitional feeding period of 4–36 months in healthy children exist. This study examined the acoustic and perceptual parameters of swallowing sounds in children aged 4–36 months over a range of food and fluid consistencies. Using CA, swallowing sounds were recorded from a microphone as children ate or drank. Acoustic parameters of duration, peak frequency and peak intensity were determined. Perceptual parameters of swallowing/breath sounds heard pre-, during and post-swallow were rated (‘present’, ‘absent’, ‘cannot be determined’) for each texture. 74 children (35 males; mean age = 17.1 months [SD 10.0]) demonstrated mean swallow durations of <1 s. Increasing age correlated to reduced peak frequency on puree (r = −0.48, 95 % CI −0.66, −0.24). Age correlated to peak amplitude when swallowing puree (r = 0.27, 95 % CI 0.02, 0.49), chewable solids (r = 0.31, 95 % CI 0.02, 0.56) and thin fluids (r = 0.48, 95 % CI 0.27, 0.64). The bolus transit sound was present in all swallows. A majority of children had normal breathing sounds and coordinated swallows. A swallow duration of <1 s and the presence of a quick bolus transit sound with normal breathing sounds were found in healthy children. The normative data reported in this study provide a platform for future comparison to abnormal swallowing sounds in children

Clinical feeding examination with cervical auscultation for detecting oropharyngeal aspiration: a&nbsp;systematic review of the evidence

Background: Cervical auscultation (i.e. listening to swallowing sounds) is the most commonly used technique in adjuvant to the clinical feeding examination by speech-language pathologists worldwide to assess for oropharyngeal aspiration risk in children. Despite its relative popularity in clinical practice, little is known on the clinical utility of cervical auscultation within a paediatric population. Objective: To determine the diagnostic test accuracy of the clinical feeding examination with cervical auscultation in the detection of aspiration in children. Type of review: Narrative review. Prospero Registration: CRD42017081467 Search strategy: Medline/Pub Med, Embase, CINAHL, AustHealth, Cochrane and UQ (Scopus) were searched up until October 2017. Specifically, the search terms used were: (((oropharyngeal OR respiratory) aspiration) AND (child* OR pediatr* OR paediatr*) and (cervical auscultation OR swallow sounds OR swallowing sounds OR accelerometry OR swallowing acoustics)). The search strategy also included scanning reference lists and citations of retrieved studies. Evaluation method: Extracted studies were reviewed by two independent reviewers. Methodological quality of studies was assessed using the QUADAS-2 tool. Results: Only one study met inclusion criteria for this review, which had a bias for flow and timing. Use of cervical auscultation in conjunction with the clinical feeding examination to predict aspiration had a positive predictor value (PPV) of only 0.49 (0.31-0.66), indicating potential over-prediction of aspiration when cervical auscultation is used. In contrast a high NPV of 0.92 (0.78-0.98) was reported indicating that cervical auscultation is useful at ruling out aspiration in children. Conclusion: This review highlights the paucity of research studies assessing the accuracy of cervical auscultation as an adjuvant to the clinical feeding examination in aspiration detection within the paediatric population

Aspirating and non-aspirating swallow sounds in children: A pilot study

<b>Background</b>\ud \ud - <i>Cervical auscultation(CA)</i> may be used to complement feeding/swallowing evaluations when assessing for aspiration. There are no published paediatric studies that compare the properties of sounds between aspirating and non-aspirating swallows. \ud \ud <b>Aim</b>\ud \ud - To establish acoustic and perceptual profiles of aspirating and non-aspirating swallow sounds; and to determine if a difference exists between these two swallowing types. \ud \ud <b>Methods</b>\ud \ud - Aspiration sound clips were obtained from recordings using CA simultaneously undertaken with videofluoroscopic swallow study. Aspiration was determined using the Penetration-Aspiration Scale. The presence of perceptual swallow/breath parameters was rated by two speech pathologists who were blinded to the type of swallow. Acoustic data between groups were compared using Mann Whitney U-tests, while perceptual differences were determined by a test of two proportions. Combinations of perceptual parameters of 50 swallows (27 aspiration, 23 no aspiration) from 47 children (57% male) were statistically analysed using area under a receiver operating characteristic<i>(aROC)</i>, sensitivity, specificity and positive and negative predictive values to determine predictors of aspirating swallows. \ud \ud <b>Results</b>\ud \ud - The combination of post-swallow presence of: wet breathing and wheeze; and absence of: GRS and normal breathing was the best predictor of aspiration (aROC 0.82, 95%CI 0.70 – 0.94). There were no significant differences between these two swallow types for peak frequency, duration and peak amplitude. \ud \ud <b>Conclusion</b>\ud \ud - Our pilot study has shown that certain characteristics of swallow obtained using CA maybe useful in the prediction of aspiration. However, further research comparing the acoustic swallowing sound profiles of normal children to children with dysphagia (who are aspirating) on a larger scale is required

Reliability for detecting oropharyngeal aspiration in children using cervical auscultation

Purpose: Limited data exist that support the reproducibility of cervical auscultation (CA) use in children. This study aimed to determine the reliability of CA in detecting oropharyngeal aspiration (OPA) in children within a controlled environment. Method: This observational study included eight speech-language pathologists who rated clips of 40 normal and 40 OPA swallowing sounds on two separate occasions (i.e.160 sound clips rated by each speech-language pathologist) to comprise a total of 1280 swallow clips rated. Swallowing sound clips were collected from (1) a volunteer sample of 20 healthy children from the general community (mean 16.2 ± 10.7 months; 65% female); (2) a referred sample of 19 children with demonstrated OPA (mean 22.8 ± 25.5 months; 36.8% female), as determined on videofluoroscopic swallow studies (VFSS) using the Penetration-Aspiration Scale (PAS) (≥6 score). Result: Inter-rater reliability was very good (kappa =0.81, 95%CI 0.79–0.84). Intra-rater reliability for each rater was good to very good (kappa range 0.72–0.98). Overall sensitivity was 93.9% (95%CI 91.8–95.6) and specificity was 94.5% (95%CI 92.5–96.2). High reliability values were found for the detection of OPA versus normal swallows using CA alone. Conclusion: Future research should investigate the use of CA in a variety of clinical settings with less environmental control before CA can be advocated for use in routine clinical practice

Using an Automated Speech Recognition Approach to Differentiate Between Normal and Aspirating Swallowing Sounds Recorded from Digital Cervical Auscultation in Children

Use of machine learning to accurately detect aspirating swallowing sounds in children is an evolving field. Previously reported classifiers for the detection of aspirating swallowing sounds in children have reported sensitivities between 79 and 89%. This study aimed to investigate the accuracy of using an automatic speaker recognition approach to differentiate between normal and aspirating swallowing sounds recorded from digital cervical auscultation in children. We analysed 106 normal swallows from 23 healthy children (median 13 months; 52.1% male) and 18 aspirating swallows from 18 children (median 10.5 months; 61.1% male) who underwent concurrent videofluoroscopic swallow studies with digital cervical auscultation. All swallowing sounds were on thin fluids. A support vector machine classifier with a polynomial kernel was trained on feature vectors that comprised the mean and standard deviation of spectral subband centroids extracted from each swallowing sound in the training set. The trained support vector machine was then used to classify swallowing sounds in the test set. We found high accuracy in the differentiation of aspirating and normal swallowing sounds with 98% overall accuracy. Sensitivity for the detection of aspiration and normal swallowing sounds were 89% and 100%, respectively. There were consistent differences in time, power spectral density and spectral subband centroid features between aspirating and normal swallowing sounds in children. This study provides preliminary research evidence that aspirating and normal swallowing sounds in children can be differentiated accurately using machine learning techniques.</p

Acoustic and perceptual profiles of swallowing sounds in children: normative data for 4–36 months from a cross-sectional study cohort

Limited data on cervical auscultation (CA) sounds during the transitional feeding period of 4–36\ua0months in healthy children exist. This study examined the acoustic and perceptual parameters of swallowing sounds in children aged 4–36\ua0months over a range of food and fluid consistencies. Using CA, swallowing sounds were recorded from a microphone as children ate or drank. Acoustic parameters of duration, peak frequency and peak intensity were determined. Perceptual parameters of swallowing/breath sounds heard pre-, during and post-swallow were rated (‘present’, ‘absent’, ‘cannot be determined’) for each texture. 74 children (35 males; mean age\ua0=\ua017.1\ua0months [SD 10.0]) demonstrated mean swallow durations o

The use of cervical auscultation to predict oropharyngeal aspiration in children: a randomized controlled trial

In this study, we aimed to determine if the use of cervical auscultation (CA) as an adjunct to the clinical feeding evaluation (CFE + CA) improves the reliability of predicting oropharyngeal aspiration (abbreviated to aspiration) in children. The design of the study is based on open label, randomized controlled trial with concealed allocation. Results from children (< 18 years) randomized to either CFE or CFE + CA were compared to videofluoroscopic swallow study (VFSS), the reference standard data. Aspiration was defined using the Penetration-Aspiration Scale. All assessments were undertaken at a single tertiary pediatric hospital. 155 children referred for a feeding/swallowing assessment were randomized into the CFE n = 83 [38 males; mean age = 34.9 months (SD 34.4)] or CFE + CA n = 72 [43 males; mean age = 39.6 months (SD 39.3)] group. kappa statistic, sensitivity, and specificity values, area under receiver operating curve (aROC). No significant differences between groups were found, although CFE + CA (kappa = 0.41, 95 % CI 0.2-0.62) had higher agreement for aspiration detection by VFSS, compared to the clinical feeding exam alone (kappa = 0.31, 95 % CI 0.10-0.52). Sensitivity was 85 % (95 % CI 62.1-96.8) for CFE + CA and 63.6 % (95 % CI 45.1-79.6) for CFE. aROC was not significantly greater for CFE + CA (0.75, 95 % CI 0.65-0.86) than CFE (0.66, 95 % CI 0.55-0.76) across all age groups. Although using CA as an adjunct to the clinical feeding evaluation improves the sensitivity of predicting aspiration in children, it is not sensitive enough as a diagnostic tool in isolation. Given the serious implications of missing the diagnosis of aspiration, instrumental assessments (e.g., VFSS), remain the preferred standard

The effect of different service models on quality of care in the assessment of autism spectrum disorder in children: study protocol for a multi-centre randomised controlled trial

BACKGROUND: There is significant variability in clinical pathways available in the diagnostic assessment of ASD, including the order and timing of allied health assessments in relation to paediatrician consultations. Allied health professionals in first-contact models are increasingly used to improve the timeliness of healthcare access, whilst complementing medical specialty workforce shortages. Anecdotally, the implementation of allied health first-contact models in paediatrics has improved waitlists and timely access to healthcare. However, no rigorous studies have been conducted to evaluate the outcomes of these models. This study aims to determine the impacts of an allied health first-contact model on health service use and costs and patient quality of life and satisfaction. METHODS: An open, semi-blinded, multi-centre randomised controlled trial in paediatric outpatient clinics at two Australian metropolitan public hospitals. 56 children (0-16 years) fulfilling the inclusion criteria will be randomised to one of two clinical pathways for assessment of ASD: (1) allied health first-contact or (2) medical first-contact model. Cost outcomes will be collected from both health service and family perspectives. Caregiver-reported outcome measures include: Pediatric Quality of Life Inventory (PedsQL), the EuroQOL Five Dimension Youth Version (EQ-5D-Y), the Autism Family Experience Questionnaire (AFEQ) and Measure of Processes of Care. DISCUSSION: Evidence of improvements in service and consumer centric outcomes will help inform the development and implementation of high-value, evidenced based models of care for the assessment of ASD in children. The findings from this study are expected to contribute to the evidence base around the costs and consequences of allied health first contact models for the assessment of children with ASD in the Australian setting. Findings of this study may help to inform the allocation of health care resources while maintaining, or potentially improving, patient and family quality of life and experience of care. These findings may be useful in informing the wider adoption of these models in Australia and internationally, particularly in healthcare settings where medical specialist shortages exist. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR) ACTRN12621001433897 . Registered: 25th October, 2021.</p