Effect of Saline Lubrication on Post-intubation Complications

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02492646
Collaborator
(none)
300
1
2
17.1
17.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Saline group
  • Procedure: Dry group
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Experimental: Dry group

In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.

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

Outcome Measures

Primary Outcome Measures

  1. incidence of postoperative sore throat (POST) [until one day after surgery]

    ask patients whether they have sore throat after surgery

Secondary Outcome Measures

  1. 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

  2. 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.

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Study Chair: Jeong-Hwa Seo, Associate professor, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeong-Hwa Seo, Pf., Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02492646
Other Study ID Numbers:
  • JHSeo_Saline
First Posted:
Jul 9, 2015
Last Update Posted:
Jun 2, 2017
Last Verified:
Jun 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2017