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Effect of Saline Lubrication on Post-intubation Complications

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02492646
Acronym
Lubrication
Enrollment
300
Registered
2015-07-09
Start date
2015-08-31
Completion date
2017-01-31
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sore Throat

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.

Interventions

PROCEDURESaline group

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

PROCEDUREDry group

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postoperative sore throat (POST)until one day after surgeryask patients whether they have sore throat after surgery

Secondary

MeasureTime frameDescription
Oropharyngeal injury2 hours and 24 hours after surgeryassessed 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 symptoms1 week after the surgeryAt 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.
severity of postoperative sore throat (POST)When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgeryThe 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026