Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
- Conditions
- Laryngeal CancerDysphagia
- Interventions
- Procedure: Transoral endoscopic laser cordectomyProcedure: Open partial horizontal laryngectomy(OPHL), Type I-III
- Registration Number
- NCT06024980
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
Recruited patients are divided into two arms depending on laryngeal carcinoma's 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-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). 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 dysphagia's 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Age: 18-80 years
- Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma
- Availability of clinical data
- Validity of normal swallowing of thin liquids
- Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease
- Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
- Radiotherapy histology
- Swallowing disorder or trachea aspiration before surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Supraglottic and glottic T1 laryngeal carcinoma Transoral endoscopic laser cordectomy The transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1 Supraglottic and glottic T2 laryngeal carcinoma Open partial horizontal laryngectomy(OPHL), Type I-III The open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2
- Primary Outcome Measures
Name Time Method Fiberoptic laryngoscope evaluation of swallowing Pre-operation, one week post-operation, two months post-operation, six months post-operation The patient, in a sitting position, had to swallow liquid. The tip of a flexible endoscope was positioned beyond the soft palate, and the pharyngeal phase of swallowing was studied, recording videos and images for further analysis. In particular, according to the severity scale, the scores ranged from 1 point (no materials entered the airway) to 8 points (the material penetrated below the vocal cords, but no effort was made to eject the material), representing the severity of risk for penetration
EAT-10 questionnaire At one day before surgery, two months after surgery, six months after surgery The EAT-10 questionnaire consists of a 10-item questionnaire with a maximum total score of 40 points. All items are rated on a 5-point scale in which 0 indicates no problem, and 4 indicates a severe problem in swallowing function. An EAT-10 score of over 3 is abnormal and indicates a higher self-perception of the presence of dysphagia.
direct subglottic pressure At one day before surgery, one week after surgery, two months after surgery, six months after surgery Subglottic pressure was measured while swallowing a thinned solution with and without airflow delivery through the subglottic puncture needle. The unit of subglottic pressure is cmH20.
Swallowing ability to four different textures At one day before surgery, one week after surgery, two months after surgery, six months after surgery An early 5-point scoring system (score one corresponding to the early postoperative assessment) was applied to each patient depending on his ability to swallow one to four different textures (liquid, semi-liquid, semi-solid, and solid). A score of 0 is poor (no power to swallow), while a score of 4 is good.
- Secondary Outcome Measures
Name Time Method Voice acoustic analysis At one day before surgery, six months after surgery Every participant was asked to phonate a sustained vowel /a/ at a habitual comfortable pitch and intensity for voice pitch, quality assessments, and habitual vocal intensity. The recordings were made in a quiet clinical room. The participant sat in front of a microphone positioned approximately 10cm from the left corner of the mouth. The voice signal coupled with Roland's Audio interface with a sampling rate of 44k-Hz and 16-bit accuracy. The signal was stored in a computer system after collecting sustained vowels. The voice signals were analyzed using speech analysis software. The stable phase of the voice sample was extracted for analysis. The 3,000-msec sample was analyzed for acoustic parameters. The voice acoustic parameters include F0 (fundamental frequency) in Hertz(Hz), percentage of jitter(%), percentage of shimmer(%), Harmonic to noise ratio(HNR), and intensity in decibels(dB).
The time in weeks of nasogastric feeding At two months after surgery, six months after surgery The duration of surgery to oral feeding after withdrawing naso tube.
Trial Locations
- Locations (1)
Guangdong Provincial People's hospital
🇨🇳Guangzhou, Guangdong, China