Effect of Saline Lubrication on Post-intubation Complications

NCT ID: NCT02492646

Last Updated: 2017-06-02

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-01-31

Brief Summary

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The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.

Detailed Description

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Conditions

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Postoperative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Saline group

In the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction.

Group Type EXPERIMENTAL

Saline group

Intervention Type PROCEDURE

After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.

Dry group

In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.

Group Type EXPERIMENTAL

Dry group

Intervention Type PROCEDURE

After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.

Interventions

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Saline group

After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.

Intervention Type PROCEDURE

Dry group

After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation

Exclusion Criteria

* history of gastroesophageal reflux disease (GERD)
* congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies
* previous airway surgery; increased risk of aspiration
* coagulation disorders
* previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification ≥ 3 or thyromental distance \< 6.5 cm
* Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy
* symptoms of sore throat or upper respiratory tract infection
* expected to place nasogastric tube during perioperative period
* requiring nasotracheal intubation
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

Pf.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Hwa Seo, Associate professor

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim E, Yang SM, Yoon SJ, Bahk JH, Seo JH. The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial. Trials. 2016 Nov 25;17(1):562. doi: 10.1186/s13063-016-1699-0.

Reference Type DERIVED
PMID: 27887662 (View on PubMed)

Other Identifiers

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JHSeo_Saline

Identifier Type: -

Identifier Source: org_study_id

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