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

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06059248
Collaborator
(none)
110
1
2
20
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: the head in the "mandibular adduction" position
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

The control group used the conventional method of endotracheal intubation, the operation method was the same as that of the T 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.

Experimental: Research group

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 "mandibular adduction" position, and the endotracheal tube is inserted at the same time

Other: the head in the "mandibular adduction" position
Intubation was performed with the head in the "mandibular adduction" position

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia, age 18~65 years old, gender is not limited, ASA grade I or II

Exclusion Criteria:

Patients with sore throat, hoarseness, cervical spondylosis, history of tracheostomy, upper respiratory tract infection, Mallampati scoreā‰„3, patients who have participated in other clinical trials within 3 months prior to enrollment, and patients who are participating in other clinical trials.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing First Hospital Nanjing Jiangsu China 210006

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Gu Jianping, Nanjing First Hospital, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT06059248
Other Study ID Numbers:
  • KY20230330-05
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023