Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024980
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-08-21
Brief Title:
Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Department of Otolaryngology Head Neck Surg
Status:
RECRUITING
Status Verified Date:
2023-08
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:
SPPDPL
Brief Summary:
Recruited patients are divided into two arms depending on laryngeal carcinomas T1 and T2 stages Two interventions were undergone including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy OPHL During the pre-and post-operative time patients performed measurements of swallowing function including direct subglottic pressure Eating Assessment Tool-10EAT-10 questionnaire swallowing ability to different textures and fiberoptic evaluation of swallowingFEES Patients undergo subglottic pressure measurement and swallowing function evaluation three times 3-7 days two months and six months after surgery Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation
Detailed Description:
There were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma At least these patients need several months to recover Few people required surgery of total laryngectomy to maintain normal swallowing function The swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia Factors that influenced the swallowing function recovery for example the time of nasogastric feeding and tracheostomy tube removal were affected by age and diabetes
On the other hand the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy But those are not directly related to swallowing motion although they are predictors of dysphagia The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagias recovery early
Subglottic pressure is a protective factor that can reduce aspiration risk This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders Specific objectives were to verify the effect of laryngectomy on subglottic pressure
On the other hand the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy But those are not directly related to swallowing motion although they are predictors of dysphagia The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagias recovery early
Subglottic pressure is a protective factor that can reduce aspiration risk This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders Specific objectives were to verify the effect of laryngectomy on subglottic pressure
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