Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800783
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-03-02
Brief Title:
Diagnostic Accuracy of Aerodigestive Ultrasound for Predicting Swallowing Disorders
Sponsor:
Hopital Forcilles
Organization:
Hopital Forcilles
Study Overview
Official Title:
Development and Assessment of a New Ultrasound Score to Diagnose Swallowing Disorders in at Risk-out-patients
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARC-VADOC
Brief Summary:
Swallowing disorders management requires an accurate recognition of implicated anatomical structures and pathways The usual clinical assessment of swallowing disorders lacks reliability and accuracy The gold standard remains the videofluoroscopy However this imaging technique lacks reliability and standardisation Moreover videofluoroscopy is not easily available time and material consuming and exposes patients to ionisation Ultrasound imaging which can be performed at the patients bedside is a non-invasive tool It allows the evaluation of the main structures involved in all the swallowing pathways and may be a promising tool to assess the swallowing disorders An ultrasound predictive model has never been developed to diagnose swallowing disorders
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders and assess its reliability and accuracy
One hundred outpatients at risk of swallowing disorders neck cancer neurological diseases previous ICU stay will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles Hospital during a 2-year period
All patients will undergo a clinical examination by a speech-language therapist and a videofluoroscopy imaging in order to diagnose swallowing disorders Then an ultrasound examination will be performed by the ultrasonographer The ultrasonographer will be blinded from the patients status and previous clinical and imaging assessments Severity of the swallowing disorder will be assessed by the Dysphagia Outcome and Severity Scale
The tongue kinetics and thickness the laryngeal movement and the suprahyoid muscles thickness and echogenicity will be assessed by ultrasonography
Inter- and intra-reliability of ultrasound examination will be calculated The threshold of each ultrasound measurement allowing the swallowing disorders will be estimated using the ROC curve analysis Sensitivity and specificity of each ultrasound measurement will be estimated A global ultrasound predictive model will be developed after selecting variables in logistic multivariable regression Diagnostic accuracy of the global predictive model will also be assessed
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic As ultrasonography is easy-to-perform rapidly available non-invasive and inexpensive it may be a valuable alternative to videofluoroscopy in swallowing disorder diagnostic
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders and assess its reliability and accuracy
One hundred outpatients at risk of swallowing disorders neck cancer neurological diseases previous ICU stay will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles Hospital during a 2-year period
All patients will undergo a clinical examination by a speech-language therapist and a videofluoroscopy imaging in order to diagnose swallowing disorders Then an ultrasound examination will be performed by the ultrasonographer The ultrasonographer will be blinded from the patients status and previous clinical and imaging assessments Severity of the swallowing disorder will be assessed by the Dysphagia Outcome and Severity Scale
The tongue kinetics and thickness the laryngeal movement and the suprahyoid muscles thickness and echogenicity will be assessed by ultrasonography
Inter- and intra-reliability of ultrasound examination will be calculated The threshold of each ultrasound measurement allowing the swallowing disorders will be estimated using the ROC curve analysis Sensitivity and specificity of each ultrasound measurement will be estimated A global ultrasound predictive model will be developed after selecting variables in logistic multivariable regression Diagnostic accuracy of the global predictive model will also be assessed
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic As ultrasonography is easy-to-perform rapidly available non-invasive and inexpensive it may be a valuable alternative to videofluoroscopy in swallowing disorder diagnostic
Detailed Description:
Swallowing disorders management requires an accurate recognition of implicated anatomical structures and pathways The usual clinical assessment of swallowing disorders lack of reliability and accuracy The gold standard remains the videofluoroscopy However this imaging technique lacks reliability and standardisation Moreover videofluoroscopy not easily available is time and material consuming and implies ionisation Ultrasound imaging which can be performed at the patients bedside is a non-invasive tool It allows the evaluation of the main structures involved in all the swallowing pathways and may be a promising tool for swallowing disorders assessment
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders and assess its reliability and accuracy
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic As ultrasonography is easy-to-perform rapidly available non-invasive and inexpensive it may be a valuable alternative to videofluoroscopy in swallowing disorders diagnostic
1 Hypothesis The investigators hypothesise that a new ultrasound predictive model is valid and reliable to diagnose swallowing disorder
2 Objectives
Primary objective
To create a new ultrasound predictive model based on the most relevant ultrasound measurements of the swallowing structures
Secondary objectives
To assess the accuracy of the ultrasound predictive model in the swallowing disorders diagnostic
To assess the inter- and intra-reliability of the ultrasound measurements
To assess the accuracy of each ultrasound measurements
3 Study design
The prospective observational single-centre study will be performed per the ethical standards of the Declaration of Helsinki and will be reported according to the Strengthening the Reporting of Observational Studies in Epidemiology STROBE statement
4 Population
One hundred outpatients at risk of swallowing disorders neck cancer neurological diseases previous ICU stay will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles Hospital during a 2-year period All consecutive patients will be screened at hospital admission and will be included if they satisfy the eligibility criteria All patients will provide oral consent to participate in accordance with the clinical research French laws Duration of the patients participation will take 3 hours
5 Data collection Data will be recorded using a local case report form Demographic data comorbidities medical and surgical history reason for swallowing assessment will be recorded at inclusion Clinical videofluoroscopy and ultrasound measurements will also be recorded On-site monitoring is planned every month
Participants will first undergo an ultrasound examination then the clinical examination and videofluoroscopy imaging
6 Ultrasound examination
Ultrasonography will be performed using a Sonosite E2 Expert ultrasound device Digital Color Doppler Ultrasound System Sonoscape medical corp China with a 7-10 MHz linear and a 3-5 MHz probes Detailed information for ultrasound procedure is described in the research protocol Ultrasonography will be performed with the patients in near-to-supine position 30
The hyoid bone movement tongue kinetics and geniohyoid muscle measurement will be performed in a sagittal plane with the curvilinear probe The probe will be placed between the posterior border of the symphysis and the anterior margin of the hyoid bone
The anterior belly of digastric and geniohyoid muscles evaluation will be performed in a frontal plane with the linear probe The probe will be placed in the submandibular area behind the symphysis
Ultrasonographer will be blinded from all patients status and previous examination Reliability will be assessed in the first twenty participants All ultrasound measurements will be repeated twice by the first ultrasonographer to assess the intra-operator reliability A second ultrasound operator will perform all the ultrasound measurement allowing the inter-operator reliability evaluation
7 Videofluoroscopy VFSS
VFSS is a radiographic procedure that provides a direct dynamic view of oral pharyngeal and upper oesophageal function during swallowing The radiologist and SLP work as a team to follow a standard protocol for conducting this examination
During this procedure the speech-language therapist presents food and fluid mixed with barium The barium is necessary to view structures via videofluoroscopy during the swallow The following procedure will be followed 5 ml of thin fluid 5 ml of ultra-thick liquid 5 ml of solid aliment then 30 ml of thin fluid
The VFSS allow the assessment of the characteristics of the swallow and the patterns of bolus movement including initiation of the swallow nasopharyngeal reflux pharyngeal clearance and laryngeal penetration and aspiration
At any time the radiologist may not initiate or stop the examination if it may be harmful to the patient The reason to stop the test will be recorded
In case of penetration or aspiration the speech language therapist will use the Penetration-Aspiration Scale
8 Statistical plan
Continuous variables will be expressed as the mean standard deviation and compared using the Students t test if the null hypothesis is not rejected by the Shapiro-Wilk test Continuous variables will be expressed as the median interquartile range and compared with the Mann-Whitney U or Kruskal-Wallis test if the null hypothesis is rejected by the Shapiro-Wilk test For categorical variables the proportions of patients in each category will be calculated Then the groups will be compared using Chi squared test
Continuous ultrasound variables will be dichotomised or grouped by class depending on the linear relation between the logit of the swallowing disorder diagnostic and the ultrasound variable The threshold for continuous ultrasound variables will be calculated with the ROC curve analysis
A multivariate logistic regression model will be carried out to assess the relation between swallowing disorders and ultrasound measures associated in univariate analyses All statistically significant ultrasound variables will be included in the model Variable selection will be stepwise based on Akaike Information Criterion To check multicollinearity between independent variables the variance inflation factor will be calculated before performing multivariate logistic regression Multicollinearity will be regarded as present when the variance inflation factor is 5 Goodness of fit will be assessed by Hosmer-Lemeshow method
The outcome of each ultrasound variable from the multivariable logistic regression will be used to weight it in the global ultrasound predictive model
Intra- and inter-operator reliability will be assessed using the kappa coefficient for categorical variables or intra-class coefficients for continuous variables
For all tests a p-value 005 will be considered statistically significant All statistical analysis will be made using R software version 361 wwwR-projectorg
9 Sample size calculation
The investigators based the sample size calculation on the number of independent variables which will be included in the logistic multivariable regression model The investigators use the criterion of one variable per 10 events for binary logistic regression analysis The investigators plan to include the 5 most relevant ultrasound measures in the model As prevalence of swallowing disorders in our unit is estimated at 05 the investigators plan a sample size of 100 patients
Reliability will be assessed on the first 20 patients With an 80 predicted kappa a minimal value of the kappa of 50 2 observations a 95 certainty and a 80 power 20 patients will be required
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders and assess its reliability and accuracy
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic As ultrasonography is easy-to-perform rapidly available non-invasive and inexpensive it may be a valuable alternative to videofluoroscopy in swallowing disorders diagnostic
1 Hypothesis The investigators hypothesise that a new ultrasound predictive model is valid and reliable to diagnose swallowing disorder
2 Objectives
Primary objective
To create a new ultrasound predictive model based on the most relevant ultrasound measurements of the swallowing structures
Secondary objectives
To assess the accuracy of the ultrasound predictive model in the swallowing disorders diagnostic
To assess the inter- and intra-reliability of the ultrasound measurements
To assess the accuracy of each ultrasound measurements
3 Study design
The prospective observational single-centre study will be performed per the ethical standards of the Declaration of Helsinki and will be reported according to the Strengthening the Reporting of Observational Studies in Epidemiology STROBE statement
4 Population
One hundred outpatients at risk of swallowing disorders neck cancer neurological diseases previous ICU stay will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles Hospital during a 2-year period All consecutive patients will be screened at hospital admission and will be included if they satisfy the eligibility criteria All patients will provide oral consent to participate in accordance with the clinical research French laws Duration of the patients participation will take 3 hours
5 Data collection Data will be recorded using a local case report form Demographic data comorbidities medical and surgical history reason for swallowing assessment will be recorded at inclusion Clinical videofluoroscopy and ultrasound measurements will also be recorded On-site monitoring is planned every month
Participants will first undergo an ultrasound examination then the clinical examination and videofluoroscopy imaging
6 Ultrasound examination
Ultrasonography will be performed using a Sonosite E2 Expert ultrasound device Digital Color Doppler Ultrasound System Sonoscape medical corp China with a 7-10 MHz linear and a 3-5 MHz probes Detailed information for ultrasound procedure is described in the research protocol Ultrasonography will be performed with the patients in near-to-supine position 30
The hyoid bone movement tongue kinetics and geniohyoid muscle measurement will be performed in a sagittal plane with the curvilinear probe The probe will be placed between the posterior border of the symphysis and the anterior margin of the hyoid bone
The anterior belly of digastric and geniohyoid muscles evaluation will be performed in a frontal plane with the linear probe The probe will be placed in the submandibular area behind the symphysis
Ultrasonographer will be blinded from all patients status and previous examination Reliability will be assessed in the first twenty participants All ultrasound measurements will be repeated twice by the first ultrasonographer to assess the intra-operator reliability A second ultrasound operator will perform all the ultrasound measurement allowing the inter-operator reliability evaluation
7 Videofluoroscopy VFSS
VFSS is a radiographic procedure that provides a direct dynamic view of oral pharyngeal and upper oesophageal function during swallowing The radiologist and SLP work as a team to follow a standard protocol for conducting this examination
During this procedure the speech-language therapist presents food and fluid mixed with barium The barium is necessary to view structures via videofluoroscopy during the swallow The following procedure will be followed 5 ml of thin fluid 5 ml of ultra-thick liquid 5 ml of solid aliment then 30 ml of thin fluid
The VFSS allow the assessment of the characteristics of the swallow and the patterns of bolus movement including initiation of the swallow nasopharyngeal reflux pharyngeal clearance and laryngeal penetration and aspiration
At any time the radiologist may not initiate or stop the examination if it may be harmful to the patient The reason to stop the test will be recorded
In case of penetration or aspiration the speech language therapist will use the Penetration-Aspiration Scale
8 Statistical plan
Continuous variables will be expressed as the mean standard deviation and compared using the Students t test if the null hypothesis is not rejected by the Shapiro-Wilk test Continuous variables will be expressed as the median interquartile range and compared with the Mann-Whitney U or Kruskal-Wallis test if the null hypothesis is rejected by the Shapiro-Wilk test For categorical variables the proportions of patients in each category will be calculated Then the groups will be compared using Chi squared test
Continuous ultrasound variables will be dichotomised or grouped by class depending on the linear relation between the logit of the swallowing disorder diagnostic and the ultrasound variable The threshold for continuous ultrasound variables will be calculated with the ROC curve analysis
A multivariate logistic regression model will be carried out to assess the relation between swallowing disorders and ultrasound measures associated in univariate analyses All statistically significant ultrasound variables will be included in the model Variable selection will be stepwise based on Akaike Information Criterion To check multicollinearity between independent variables the variance inflation factor will be calculated before performing multivariate logistic regression Multicollinearity will be regarded as present when the variance inflation factor is 5 Goodness of fit will be assessed by Hosmer-Lemeshow method
The outcome of each ultrasound variable from the multivariable logistic regression will be used to weight it in the global ultrasound predictive model
Intra- and inter-operator reliability will be assessed using the kappa coefficient for categorical variables or intra-class coefficients for continuous variables
For all tests a p-value 005 will be considered statistically significant All statistical analysis will be made using R software version 361 wwwR-projectorg
9 Sample size calculation
The investigators based the sample size calculation on the number of independent variables which will be included in the logistic multivariable regression model The investigators use the criterion of one variable per 10 events for binary logistic regression analysis The investigators plan to include the 5 most relevant ultrasound measures in the model As prevalence of swallowing disorders in our unit is estimated at 05 the investigators plan a sample size of 100 patients
Reliability will be assessed on the first 20 patients With an 80 predicted kappa a minimal value of the kappa of 50 2 observations a 95 certainty and a 80 power 20 patients will be required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None