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

NCT ID: NCT06059248

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-07-06

Brief Summary

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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

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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

Conditions

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Endotracheal Intubation General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

the head in the "sniffing position "

Intervention Type OTHER

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

Interventions

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the head in the "sniffing position "

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gu Jianping

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 27555130 (View on PubMed)

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.

Reference Type RESULT
PMID: 31860598 (View on PubMed)

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.

Reference Type RESULT
PMID: 26787799 (View on PubMed)

Other Identifiers

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KY20230330-05

Identifier Type: -

Identifier Source: org_study_id

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