Effect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat

General Anesthesia Clinical Trial

Official title:

Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059248
• Other study ID #: KY20230330-05
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shan Tao
• Phone: +8618852095135
• Email: 858727933[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this [ randomized clinical trial] is to [effect of different head positions on the incidence of postoperative sore throat ] in [patients with endotracheal intubation ]. The main question it aims to answer is: the rate of postoperative sore throat will be reduced or not with the patients' head position changed during intubation.

Description:

Objective: To investigate the effect of tracheal intubation in different head positions on the incidence of pharyngeal pain 1, 6 and 24h after operation;Effect of tracheal intubation in different head positions on the incidence of hoarseness 1, 6 and 24h after operation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia

2. age 18~65 years old,

3. ASA grade I or II

Exclusion Criteria:

1. patients with pre-existing sore throat or hoarseness before anesthesia;

2. patients with cervical spine disease;

3. patients with upper respiratory infection or a history of tracheostomy;

4. Mallampati score = 3;

5. participation in other clinical trials within the past three months.

Related Conditions & MeSH terms

• Endotracheal Intubation
• General Anesthesia
• Pharyngitis

Intervention

Other:
• the head in the "sniffing position "
Intubation was performed with the head in the " elevation " position

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Kusunoki T, Sawai T, Komasawa N, Shimoyama Y, Minami T. Correlation between extraction force during tracheal intubation stylet removal and postoperative sore throat. J Clin Anesth. 2016 Sep;33:37-40. doi: 10.1016/j.jclinane.2015.12.024. Epub 2016 Apr 6. — View Citation

Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. — View Citation

Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative sore throat	Postoperative sore throat is defined as: persistent sore throat with the following grades: 1 point: no sore throat; 2 points: mild, accompanied by odynophagia; 3 points: moderate pain, persistent, worsening with swallowing; 4 points: severe, pain interferes with eating, requires the use of pain medication	1, 6, 24 hours after tracheal catheter removal
Secondary	Postoperative hoarseness	Hoarseness is defined as a sound quality different from the preoperative voice and is graded as follows: 1 point: none, no hoarseness; 2 points: slight hoarseness, noticed by the patient; 3 points: moderate hoarseness, pronounced to observer; 4 points: severe hoarseness, loss of voice.	1, 6, 24 hours after tracheal catheter removal