Effect of Saline Lubrication on Post-intubation Complications

Study Overview
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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.

Official Title
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Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial

Conditions
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Postoperative Sore Throat

Intervention / Treatment
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* Procedure: Saline group
* Procedure: Dry group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline group<br>In the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction. | Procedure: Saline group<br>* After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.<br>|
| Experimental: Dry group<br>In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation. | Procedure: Dry group<br>* After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative sore throat (POST) | ask patients whether they have sore throat after surgery | until one day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal injury | 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 | 2 hours and 24 hours after surgery | 
| respiratory symptoms | 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. | 1 week after the surgery | 
| severity of postoperative sore throat (POST) | 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) | When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery |