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

Not Applicable

Completed

• Conditions: Endotracheal Intubation; General Anesthesia

• Registration Number: NCT06059248
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed 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

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Participants with postoperative sore throat	1, 6, 24 hours after tracheal catheter removal	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

Secondary Outcome Measures

Name	Time	Method
Rate of Participants with postoperative hoarseness	1, 6, 24 hours after tracheal catheter removal	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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China