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

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ClinicalTrials.gov Identifier: NCT06059248
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Study Description
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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
Endotracheal Intubation General Anesthesia Other: the head in the "sniffing position " Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arms and Interventions
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Arm Intervention/treatment
No Intervention: head sniffing position group
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.
Experimental: head elevation position 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 "elevation" position, and the endotracheal tube is inserted at the same time
 Other: the head in the "sniffing position "
Intubation was performed with the head in the " elevation " position


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative sore throat [ Time Frame: 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. Postoperative hoarseness [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06059248


Contacts
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Contact: Shan Tao +8618852095135 858727933@qq.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Gu Jianping    025-52271064      
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Chair: Gu Jianping Nanjing First Hospital, Nanjing Medical University
More Information
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Publications of Results:

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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT06059248    
Other Study ID Numbers: KY20230330-05
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
 Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases