Back to resultsEffect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat
Primary Purpose
Endotracheal Intubation, General Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the head in the "mandibular adduction" position
Sponsored by
About this trial
This is an interventional prevention trial for Endotracheal Intubation
Eligibility Criteria
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 score≥3, patients who have participated in other clinical trials within 3 months prior to enrollment, and patients who are participating in other clinical trials.
Sites / Locations
- Nanjing First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Research group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06059248
First Posted
September 22, 2023
Last Updated
September 22, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06059248
Brief Title
Effect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat
Official Title
Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotracheal Intubation, General Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Research group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
the head in the "mandibular adduction" position
Intervention Description
Intubation was performed with the head in the "mandibular adduction" position
Primary Outcome Measure Information:
Title
sore throat
Description
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
Time Frame
1, 6, 24 hours after tracheal catheter removal
Secondary Outcome Measure Information:
Title
hoarseness
Description
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.
Time Frame
1, 6, 24 hours after tracheal catheter removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 score≥3, patients who have participated in other clinical trials within 3 months prior to enrollment, and patients who are participating in other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shan Tao
Phone
+8618852095135
Email
858727933@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gu Jianping
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gu Jianping
Phone
025-52271064
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27555130
Citation
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.
Results Reference
result
PubMed Identifier
31860598
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. doi: 10.1097/EJA.0000000000001149.
Results Reference
result
PubMed Identifier
26787799
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):282-8. doi: 10.1093/bja/aev414.
Results Reference
result
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Effect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat
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