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Completed

NCT Number: NCT02492646

Effect of Saline Lubrication on Post-intubation Complications

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.

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Key information

Conditions

Postoperative Sore Throat

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline group

Procedure

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

Dry group

Procedure

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

Primary outcomes

  1. incidence of postoperative sore throat (POST)

    Time frame: until one day after surgery

    ask patients whether they have sore throat after surgery

Secondary outcomes

  1. Oropharyngeal injury

    Time frame: 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

  2. respiratory symptoms

    Time frame: 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.

  3. severity of postoperative sore throat (POST)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: Lubrication

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 9, 2015
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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