Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

NCT06505850 | Completed FDA Device

• 1 other identifier: A202405086_V3
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Postoperative Sore Throat; Subglottic Airway Injury; Endotracheal Tube Cuff

Keywords

Endotracheal tube cuff; Postoperative sore throat; Subglottic airway injury; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• The incidence of postoperative sore throat

  Postoperative 48 hours

• The severity of postoperative sore throat

  1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)

  Postoperative 48 hours

Secondary Outcomes (4)

• Intraoperative fentanyl consumption

  The end of surgery

• Intraoperative propofol consumption

  The end of surgery

• Intraoperative rocuronium consumption

  The end of surgery

• The degree of subglottic injury

  Intraoperative (The time point at extubation)

Study Arms (2)

Tapered-shaped cuff ETT group

EXPERIMENTAL

A tapered-shaped cuff tube was used to intubate for general anesthesia

Device: Tapered-shaped cuff tracheal tube

Cylindrical-shaped cuff ETT group

ACTIVE COMPARATOR

A cylindrical-shaped cuff tube was used to intubate for general anesthesia

Device: Cylindrical-shaped cuff tracheal tube

Interventions

Tapered-shaped cuff tracheal tube DEVICE

Tracheal intubation with a tapered-shaped cuff tube

Tapered-shaped cuff ETT group

Cylindrical-shaped cuff tracheal tube DEVICE

Tracheal intubation with a cylindrical-shaped cuff tube

Cylindrical-shaped cuff ETT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (7)

• 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.

  PMID: 2331067 BACKGROUND

• 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.

  PMID: 7880666 BACKGROUND

• 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.

  PMID: 15892411 BACKGROUND

• 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.

  PMID: 20206846 BACKGROUND

• 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.

  PMID: 27158989 BACKGROUND

• 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.

  PMID: 28368938 BACKGROUND

• Chen GC, Lo KL, Wu ZF, Chan SM, Cheng SY, Ko CL, Chu CM, Tseng WC. Comparison of the incidence and severity of postoperative sore throat and subglottic airway injury with cylindrical versus tapered cuff endotracheal tubes in women undergoing surgery for breast cancer: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 12;25(1):181. doi: 10.1186/s12871-025-03040-y.

  PMID: 40221641 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 17, 2024
• Study Start: July 22, 2024
• Primary Completion: December 13, 2024
• Study Completion: January 3, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)