Effect of Saline Lubrication on Post-intubation Complications

Postoperative Sore Throat Clinical Trial

— Lubrication  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492646
• Other study ID #: JHSeo_Saline
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: June 1, 2017
• Start date: August 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

Procedure:
• Saline group
After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.
• Dry group
After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative sore throat (POST)	ask patients whether they have sore throat after surgery	until one day after surgery
Secondary	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
Secondary	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
Secondary	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