Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630013
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
A New Ultrasound Score for Swallowing Disorders Diagnosis in Difficult-to-wean Tracheostomised Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Construction and Evaluation of a New Ultrasound Score for the Diagnosis of Swallowing Disorders in Difficult-to-wean Tracheostomised Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHUBACA
Brief Summary:
Swallowing Disorders SD is commonly observed in intensive care unit ICU patients
Disruption to the upper airway by way of a tracheostomy may lead to physiological andor biomechanical changes to the swallow thereby increasing dysphagia risk SD is independently associated with adverse outcomes including respiratory complications nutritional compromise and even death
Experts recommend a systematic bedside screening Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients
However the clinical examination lacks precision Complementary examinations such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are irradiating or invasive consume numerous resources and are difficult to access No current consensus exists on how to best approach to evaluate ICU patients at risk
In this context US imaging has garnered increased interest for assessing swallowing disorders Recognised for its non-invasive nature and its ability to overcome conventional constraints this approach enabling both qualitative and quantitative analysis of multiple structures would enhance the precision in targeting structures for rehabilitation
The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients Additionally they aim to evaluate the reliability and accuracy of this model
During an nineteen-months period we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilless Hospital Universitary Hospital of Dijon Béthune Hospital and Bourgon Jallieu Hospital
All patients will have a FEES evaluation The ultrasonographer will be blinded to the patients status and prior clinical or imaging assessments Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue laryngeal movement or suprahyoid muscles
A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression Its sensitivity and specificity and prediction value will be estimated The constructed model will be transformed in an easy-to-use scoring system
The study anticipates establishing an association between ultrasound markers and swallowing disorders aiming to enhance early detection for tailored management strategies providing a non-invasive alternative to videofluoroscopy or FEES
Disruption to the upper airway by way of a tracheostomy may lead to physiological andor biomechanical changes to the swallow thereby increasing dysphagia risk SD is independently associated with adverse outcomes including respiratory complications nutritional compromise and even death
Experts recommend a systematic bedside screening Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients
However the clinical examination lacks precision Complementary examinations such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are irradiating or invasive consume numerous resources and are difficult to access No current consensus exists on how to best approach to evaluate ICU patients at risk
In this context US imaging has garnered increased interest for assessing swallowing disorders Recognised for its non-invasive nature and its ability to overcome conventional constraints this approach enabling both qualitative and quantitative analysis of multiple structures would enhance the precision in targeting structures for rehabilitation
The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients Additionally they aim to evaluate the reliability and accuracy of this model
During an nineteen-months period we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilless Hospital Universitary Hospital of Dijon Béthune Hospital and Bourgon Jallieu Hospital
All patients will have a FEES evaluation The ultrasonographer will be blinded to the patients status and prior clinical or imaging assessments Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue laryngeal movement or suprahyoid muscles
A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression Its sensitivity and specificity and prediction value will be estimated The constructed model will be transformed in an easy-to-use scoring system
The study anticipates establishing an association between ultrasound markers and swallowing disorders aiming to enhance early detection for tailored management strategies providing a non-invasive alternative to videofluoroscopy or FEES
Detailed Description:
Intensive Care Unit ICU stays often lead to Swallowing Disorders SD Physiological and biomechanical changes due to tracheostomy increase the risk of SD which can have serious consequences for quality of life and overall health
Experts recommend systematic bedside screening Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening-positive patients Early intervention strategies could greatly benefit highlighting the importance of assessments identifying which specific structures require intervention and enabling a targeted rehabilitation approach However clinical examinations lack precision
Complementary examinations such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are irradiating or invasive consume numerous resources and are difficult to access In this context ultrasound imaging has garnered increased interest for assessing swallowing disorders Recognized for its non-invasive nature and its ability to overcome conventional constraints ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation This approach enabling both qualitative and quantitative analysis of multiple structures would enhance precision in targeting structures for rehabilitation
A recent study shows strong potential for an ultrasound prediction model for diagnosing swallowing disorders in outpatients The researchers intend to create an ultrasound diagnostic model for difficult-to-wean tracheostomized patients Additionally they aim to evaluate the reliability and accuracy of this model Hypothesis The investigators hypothesize that an ultrasound predictive model is valid and reliable for diagnosing swallowing disorders in difficult-to-wean tracheostomized patients
Main objective The primary aim is to develop an ultrasound predictive model based on the most relevant ultrasound measurements of the aerodigestive tract
Secondary objectives
To evaluate the validity and reliability of a new ultrasound score for diagnosing swallowing disorders
To assess the reliability and validity of tongue movement in diagnosing swallowing disorders
To evaluate the reliability and validity of hyoid bone movement in diagnosing swallowing disorders
To assess the reliability and validity of digastric muscle ultrasound evaluation in diagnosing swallowing disorders
To evaluate the reliability and validity of genohyoid muscle ultrasound evaluation fraction in diagnosing swallowing disorders
Study design
This prospective observational multicenter study will adhere to the ethical standards of the Declaration of Helsinki and will be reported according to the standards for transparent reporting of a multivariable prediction model for individual prognosis or diagnosis guidelines TRIPOD
Population
One hundred and nineteen difficult-to-wean tracheostomized patients will be enrolled All consecutive patients with difficult-to-wean tracheostomies will be screened and those meeting the eligibility criteria will be enrolled Patients will provide oral consent to participate in accordance with French clinical research laws Data collection Fiberoptic Endoscopic Evaluation of Swallowing FEES and ultrasound US evaluations will be conducted within a two-hour timeframe
Data collection
Data will be recorded using an online case report form Datacapt Demographic data comorbidities medical and surgical history will be recorded at enrollment On-site monitoring is planned monthly
Ultrasound examination
Ultrasonography will be performed using both linear and convex probes The ultrasonographer will be blinded to the patients status and prior clinical or imaging assessments All measurements will be performed in a semi-recumbent position 30 with the neck in a neutral position Subjects will be asked to swallow saliva to assess active movements and muscle contractions Parameters such as tongue thickness movement and echointensity hyoid bone movement and suprahyoid muscle characteristics thickness cross-sectional area and echointensity will be evaluated Suprahyoid muscles will be assessed both at rest and during swallowing and muscle contraction ratios will be calculated accordingly Detailed information on the ultrasound procedure is described in the research protocol
To assess inter-examiner reliability during the initial ultrasound evaluation tests will be conducted by two different operators on a consecutive sample of patients To limit the examination time for each patient another consecutive sample of patients will be used for intra-examiner reliability For the patients involved in the reliability assessment an additional 10 minutes will be allocated
FEES
They will be performed by the attending physician in the patients room A physiotherapist or speech-language therapist will be present to assess swallowing and the involved structures systematically
Evaluators will examine the integrity and functionality of structures such as the arytenoids or vocal cords and assess laryngeal and hypopharyngeal sensitivity The examination will conclude with swallowing trials using various textures to observe swallowing enabling identification of any inhalation Different bolus consistencies viscosities and volumes will be used during the assessment to evaluate the patients full range of dietary options based on preswallow assessments The Yale Pharyngeal Residue Severity Rating Scale will be used to characterize the severity and localization of residues observed after each swallowing trial
Statistical plan
Descriptive statistics will summarize quantitative variables with means standard deviation or medians minimum-maximum while qualitative variables will be described using numbers and percentages Univariate comparisons will employ standard statistical tests such as Chi-square Fishers test t-test ANOVA Wilcoxon or Kruskal-Wallis tests with a significance level of 5 and 95 confidence intervals Association measures between variables will use Pearsons or Spearmans correlation coefficients for quantitative data and Chi-square or Fishers tests for qualitative data Agreement assessment will utilize the Bland-Altman method for quantitative variables and the Kappa coefficient for qualitative variables
To establish an ultrasound diagnostic model for diagnosing swallowing disorders variables will be dichotomized based on a linear relationship hypothesis tested using ROC curve analysis Patients will be categorized into positive presence of swallowing disorders and negative groups absence of swallowing disorders using FEES diagnosis Ultrasound variables differing significantly between these groups p 020 will be included in multivariate logistic regression guided by Akaikes information criterion AIC for variable selection while considering multicollinearity The multivariate logistic regression scores will weight each ultrasound variable Researchers will transform the model into an easy-to-use scoring system
Validity will be determined by ROC curve analysis to establish the ultrasound score threshold for diagnosing swallowing disorders Sensitivities specificities positive and negative predictive values and diagnostic odds ratios will assess the scores diagnostic accuracy Reliability assessed with a correlation coefficient ρ080 requires a sample of 20 patients for a desired correlation coefficient ρ0050 ensuring sufficient power α005 β020 Inter- and intra-examiner reproducibility will be evaluated using the Kappa coefficient
Sample size calculation
According to Harrells recommendations on the construction of multivariate models a maximum of 1 variable per 10 events should be included The prevalence of swallowing disorders in our patient population is highly variable in the literature eg 11-93 according to Skoretz or 50-83 according to Garuti et al Based on our PMSI data we estimate the prevalence of swallowing disorders at 65 We aim to include a maximum of 4 variables in the multivariate model ie 114 patients are required
Experts recommend systematic bedside screening Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening-positive patients Early intervention strategies could greatly benefit highlighting the importance of assessments identifying which specific structures require intervention and enabling a targeted rehabilitation approach However clinical examinations lack precision
Complementary examinations such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing FEES are irradiating or invasive consume numerous resources and are difficult to access In this context ultrasound imaging has garnered increased interest for assessing swallowing disorders Recognized for its non-invasive nature and its ability to overcome conventional constraints ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation This approach enabling both qualitative and quantitative analysis of multiple structures would enhance precision in targeting structures for rehabilitation
A recent study shows strong potential for an ultrasound prediction model for diagnosing swallowing disorders in outpatients The researchers intend to create an ultrasound diagnostic model for difficult-to-wean tracheostomized patients Additionally they aim to evaluate the reliability and accuracy of this model Hypothesis The investigators hypothesize that an ultrasound predictive model is valid and reliable for diagnosing swallowing disorders in difficult-to-wean tracheostomized patients
Main objective The primary aim is to develop an ultrasound predictive model based on the most relevant ultrasound measurements of the aerodigestive tract
Secondary objectives
To evaluate the validity and reliability of a new ultrasound score for diagnosing swallowing disorders
To assess the reliability and validity of tongue movement in diagnosing swallowing disorders
To evaluate the reliability and validity of hyoid bone movement in diagnosing swallowing disorders
To assess the reliability and validity of digastric muscle ultrasound evaluation in diagnosing swallowing disorders
To evaluate the reliability and validity of genohyoid muscle ultrasound evaluation fraction in diagnosing swallowing disorders
Study design
This prospective observational multicenter study will adhere to the ethical standards of the Declaration of Helsinki and will be reported according to the standards for transparent reporting of a multivariable prediction model for individual prognosis or diagnosis guidelines TRIPOD
Population
One hundred and nineteen difficult-to-wean tracheostomized patients will be enrolled All consecutive patients with difficult-to-wean tracheostomies will be screened and those meeting the eligibility criteria will be enrolled Patients will provide oral consent to participate in accordance with French clinical research laws Data collection Fiberoptic Endoscopic Evaluation of Swallowing FEES and ultrasound US evaluations will be conducted within a two-hour timeframe
Data collection
Data will be recorded using an online case report form Datacapt Demographic data comorbidities medical and surgical history will be recorded at enrollment On-site monitoring is planned monthly
Ultrasound examination
Ultrasonography will be performed using both linear and convex probes The ultrasonographer will be blinded to the patients status and prior clinical or imaging assessments All measurements will be performed in a semi-recumbent position 30 with the neck in a neutral position Subjects will be asked to swallow saliva to assess active movements and muscle contractions Parameters such as tongue thickness movement and echointensity hyoid bone movement and suprahyoid muscle characteristics thickness cross-sectional area and echointensity will be evaluated Suprahyoid muscles will be assessed both at rest and during swallowing and muscle contraction ratios will be calculated accordingly Detailed information on the ultrasound procedure is described in the research protocol
To assess inter-examiner reliability during the initial ultrasound evaluation tests will be conducted by two different operators on a consecutive sample of patients To limit the examination time for each patient another consecutive sample of patients will be used for intra-examiner reliability For the patients involved in the reliability assessment an additional 10 minutes will be allocated
FEES
They will be performed by the attending physician in the patients room A physiotherapist or speech-language therapist will be present to assess swallowing and the involved structures systematically
Evaluators will examine the integrity and functionality of structures such as the arytenoids or vocal cords and assess laryngeal and hypopharyngeal sensitivity The examination will conclude with swallowing trials using various textures to observe swallowing enabling identification of any inhalation Different bolus consistencies viscosities and volumes will be used during the assessment to evaluate the patients full range of dietary options based on preswallow assessments The Yale Pharyngeal Residue Severity Rating Scale will be used to characterize the severity and localization of residues observed after each swallowing trial
Statistical plan
Descriptive statistics will summarize quantitative variables with means standard deviation or medians minimum-maximum while qualitative variables will be described using numbers and percentages Univariate comparisons will employ standard statistical tests such as Chi-square Fishers test t-test ANOVA Wilcoxon or Kruskal-Wallis tests with a significance level of 5 and 95 confidence intervals Association measures between variables will use Pearsons or Spearmans correlation coefficients for quantitative data and Chi-square or Fishers tests for qualitative data Agreement assessment will utilize the Bland-Altman method for quantitative variables and the Kappa coefficient for qualitative variables
To establish an ultrasound diagnostic model for diagnosing swallowing disorders variables will be dichotomized based on a linear relationship hypothesis tested using ROC curve analysis Patients will be categorized into positive presence of swallowing disorders and negative groups absence of swallowing disorders using FEES diagnosis Ultrasound variables differing significantly between these groups p 020 will be included in multivariate logistic regression guided by Akaikes information criterion AIC for variable selection while considering multicollinearity The multivariate logistic regression scores will weight each ultrasound variable Researchers will transform the model into an easy-to-use scoring system
Validity will be determined by ROC curve analysis to establish the ultrasound score threshold for diagnosing swallowing disorders Sensitivities specificities positive and negative predictive values and diagnostic odds ratios will assess the scores diagnostic accuracy Reliability assessed with a correlation coefficient ρ080 requires a sample of 20 patients for a desired correlation coefficient ρ0050 ensuring sufficient power α005 β020 Inter- and intra-examiner reproducibility will be evaluated using the Kappa coefficient
Sample size calculation
According to Harrells recommendations on the construction of multivariate models a maximum of 1 variable per 10 events should be included The prevalence of swallowing disorders in our patient population is highly variable in the literature eg 11-93 according to Skoretz or 50-83 according to Garuti et al Based on our PMSI data we estimate the prevalence of swallowing disorders at 65 We aim to include a maximum of 4 variables in the multivariate model ie 114 patients are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None