Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

Dysphagia Clinical Trial

— SPPDPL  

Official title:

Department of Otolaryngology Head Neck Surg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024980
• Other study ID #: 2022-59
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Guangdong Provincial People's Hospital
• Contact: Pingjiang Ge, M.D.
• Phone: +8613751753465
• Email: gepingjiang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Laryngeal Cancer
• Laryngeal Neoplasms

Intervention

Procedure:
• Open partial horizontal laryngectomy(OPHL), Type I-III
An open partial horizontal laryngectomy(OPHL) was performed for patients with T2 supraglottic and glottic carcinoma, according to the American Joint Committee on Cancer(AJCC) criteria. Type I OPHL: Entails the resection of the supraglottis, including the pre-epiglottic space and the upper half of the thyroid cartilage. Type II OPHL: Entails the resection of the entire thyroid cartilage, with the inferior limit represented by the upper edge of the cricoid ring. Type III OPHL: Entails the resection of the entire supraglottic, glottic, and part of the subglottic sites, sparing both or at least one functioning crico-arytenoid unit.
• Transoral endoscopic laser cordectomy
For patients with T1 glottic laryngeal carcinoma, according to the criteria of the American Joint Committee on Cancer(AJCC), transoral endoscopic CO2 laser(2-40Watts) cordectomy was performed. The classification comprises eight types of cordectomies: A subepithelial cordectomy (type I) is a resection of the epithelium of the vocal fold. A subligamental cordectomy (type II) is a resection of the epithelium, Reinke's space, and vocal ligament. Transmuscular cordectomy (type III), which proceeds through the vocalis muscle. Total cordectomy (type IV). Extended cordectomy encompasses the contralateral vocal fold and the anterior commissure (type Va). Extended cordectomy, which includes the arytenoid (type Vb). Extended cordectomy, which encompasses the subglottis (type Vc). Extended cordectomy, which consists of the ventricle (type Vd).

Locations

Country	Name	City	State
China	Guangdong Provincial People's hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Alaskarov E, Ozturk O, Batioglu-Karaaltin A, Gulmez ZD, Erdur ZB, Inan HC. Functional Outcomes of the Hyaluronic Acid Injections in Patients Who Underwent Partial Laryngectomy. J Voice. 2022 May;36(3):417-422. doi: 10.1016/j.jvoice.2020.06.026. Epub 2020 Jul 22. — View Citation

Bagwell K, Leder SB, Sasaki CT. Is partial laryngectomy safe forever? Am J Otolaryngol. 2015 May-Jun;36(3):437-41. doi: 10.1016/j.amjoto.2014.11.005. Epub 2014 Nov 20. — View Citation

Breunig C, Benter P, Seidl RO, Coordes A. Predictable swallowing function after open horizontal supraglottic partial laryngectomy. Auris Nasus Larynx. 2016 Dec;43(6):658-65. doi: 10.1016/j.anl.2016.01.003. Epub 2016 Feb 4. — View Citation

Clarett M, Andreu MF, Salvati IG, Donnianni MC, Montes GS, Rodriguez MG. [Effect of subglottic air insufflation on subglottic pressure during swallowing]. Med Intensiva. 2014 Apr;38(3):133-9. doi: 10.1016/j.medin.2013.01.003. Epub 2013 Mar 6. Spanish. — View Citation

Dawson C, Pracy P, Patterson J, Paleri V. Rehabilitation following open partial laryngeal surgery: key issues and recommendations from the UK evidence based meeting on laryngeal cancer. J Laryngol Otol. 2019 Mar;133(3):177-182. doi: 10.1017/S0022215119000483. — View Citation

Fakhry N, Michel J, Giorgi R, Robert D, Lagier A, Santini L, Moreddu E, Puymerail L, Adalian P, Dessi P, Giovanni A. Analysis of swallowing after partial frontolateral laryngectomy with epiglottic reconstruction for glottic cancer. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2013-20. doi: 10.1007/s00405-013-2750-3. Epub 2013 Oct 8. — View Citation

Freitas AS, Santos IC, Furia C, Dornelas R, Silva ACAE, Dias FL, Salles GF. Prevalence and associated factors of aspiration and severe dysphagia in asymptomatic patients in the late period after open partial laryngectomy: a videofluoroscopic evaluation. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3695-3703. doi: 10.1007/s00405-021-07231-4. Epub 2022 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fiberoptic laryngoscope evaluation of swallowing	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	Pre-operation, one week post-operation, two months post-operation, six months post-operation
Primary	direct subglottic pressure	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.	At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Primary	EAT-10 questionnaire	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.	At one day before surgery, two months after surgery, six months after surgery
Primary	Swallowing ability to four different textures	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.	At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Secondary	Voice acoustic analysis	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).	At one day before surgery, six months after surgery
Secondary	The time in weeks of nasogastric feeding	The duration of surgery to oral feeding after withdrawing naso tube.	At two months after surgery, six months after surgery