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

NCT06059248 | Completed

• 1 other identifier: KY20230330-05
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endotracheal Intubation; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Rate of Participants with 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 Outcomes (1)

• Rate of Participants with postoperative hoarseness

  1, 6, 24 hours after tracheal catheter removal

Study Arms (2)

head sniffing position group

NO INTERVENTION

The sniffing position group used the conventional method of endotracheal intubation, the operation method was the same as that of the elevation position group, after the anterior part of the tracheal tube was inserted into the glottis, the head was still kept in the backward position, and the tube core was pulled out by another anesthesiologist (the core extubation force was less than 10N), and the endotracheal tube was inserted at the same time.

head elevation position group

EXPERIMENTAL

The operation methods of the research group are: left hand laryngoscope, inserted into the laryngeal cavity, fully exposed glottis, right hand tracheal tube from the right corner of the mouth into the mouth, direct vision to insert the anterior part of the endotracheal tube into the glottis, and then the assistant pulls out the tube core (the strength of the extubation core is less than 10N), so that the patient's jaw is adducted, the head remains in the "elevation" position, and the endotracheal tube is inserted at the same time

Other: the head in the "sniffing position "

Interventions

the head in the "sniffing position " OTHER

Intubation was performed with the head in the " elevation " position

head elevation position group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia
• age 18\~65 years old,
• ASA grade I or II

You may not qualify if:

• patients with pre-existing sore throat or hoarseness before anesthesia;
• patients with cervical spine disease;
• patients with upper respiratory infection or a history of tracheostomy;
• Mallampati score ≥ 3;
• participation in other clinical trials within the past three months.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related 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.

  PMID: 27555130 RESULT

• 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. doi: 10.1097/EJA.0000000000001149.

  PMID: 31860598 RESULT

• 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):282-8. doi: 10.1093/bja/aev414.

  PMID: 26787799 RESULT

Study Officials

• Gu Jianping

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

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: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 6, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)