Clinical trial NCT06505850: Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients
Official title: Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes with Different Cuff Shapes in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Postoperative Sore Throat
Subglottic Airway Injury
Endotracheal Tube Cuff
Keywords: Endotracheal tube cuff
Postoperative sore throat
Subglottic airway injury
Breast Cancer
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat

Detailed description: Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.

Eligibility criteria: Inclusion Criteria:

* Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation

Exclusion Criteria:

* Age \< 18 years or age \> 80 years
* Diseases or anatomic abnormalities in the neck, larynx, or pharynx
* Combined surgery such as breast reconstruction
* Active pulmonary disease
* Morbid obesity (body mass index ≥ 40 kg/m2)
* Pregnancy
* Refusal to join the study

Primary outcomes:
measure: The incidence of postoperative sore throat
timeFrame: Postoperative 48 hours
measure: The severity of postoperative sore throat
timeFrame: Postoperative 48 hours
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: The end of surgery
measure: Intraoperative propofol consumption
timeFrame: The end of surgery
measure: Intraoperative rocuronium consumption
timeFrame: The end of surgery
measure: The degree of subglottic injury
timeFrame: Intraoperative (The time point at extubation)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
citation: Monroe MC, Gravenstein N, Saga-Rumley S. Postoperative sore throat: effect of oropharyngeal airway in orotracheally intubated patients. Anesth Analg. 1990 May;70(5):512-6. doi: 10.1213/00000539-199005000-00008.
citation: Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
citation: Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur J Anaesthesiol. 2005 Apr;22(4):307-11. doi: 10.1017/s0265021505000529.
citation: Lehmann M, Monte K, Barach P, Kindler CH. Postoperative patient complaints: a prospective interview study of 12,276 patients. J Clin Anesth. 2010 Feb;22(1):13-21. doi: 10.1016/j.jclinane.2009.02.015.
citation: El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
citation: Chang JE, Kim H, Han SH, Lee JM, Ji S, Hwang JY. Effect of Endotracheal Tube Cuff Shape on Postoperative Sore Throat After Endotracheal Intubation. Anesth Analg. 2017 Oct;125(4):1240-1245. doi: 10.1213/ANE.0000000000001933.