Effect of Saline Lubrication on Post-intubation Complications

Not Applicable

Completed

• Conditions: Postoperative Sore Throat
• Interventions: Procedure: Saline group; Procedure: Dry group

• Registration Number: NCT02492646
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Study Start: 2015-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline group	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.
Dry group	Dry group	In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.

Primary Outcome Measures

Name	Time	Method
incidence of postoperative sore throat (POST)	until one day after surgery	ask patients whether they have sore throat after surgery

Secondary Outcome Measures

Name	Time	Method
severity of postoperative sore throat (POST)	When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery	The severity of POST was evaluated on a 4-point-scale : 0, no sore throat; 1, mild sore throat (complained of sore throat only upon inquiry); 2, moderate sore throat (complained of sore throat on his/her own); 3, severe sore throat (change of voice or hoarseness, associated with throat pain)
Oropharyngeal injury	2 hours and 24 hours after surgery	assessed by direct visualization of the oropharyngeal cavity with regard to the location such as pharyngeal wall, uvula, vallecular, tonsillar fossa and pillars and presence of hyperemia, edema, hematoma, or any other lesions
respiratory symptoms	1 week after the surgery	At the 1 week postoperative follow-up phone call, patients would be asked if they have upper respiratory symptoms such as cough, sputum, sore throat or fever. And if so, they would be checked if they diagnosed following diseases, common cold, tonsillitis, pneumonia or any other possible respiratory infectious diseases.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of