Effect of Saline Lubrication on Post-intubation Complications

NCT02492646 | Completed DMC

• 1 other identifier: JHSeo_Saline
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sore Throat

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative sore throat (POST)

  ask patients whether they have sore throat after surgery

  until one day after surgery

Secondary Outcomes (3)

• Oropharyngeal injury

  2 hours and 24 hours after surgery

• respiratory symptoms

  1 week after the surgery

• severity of postoperative sore throat (POST)

  When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery

Study Arms (2)

Saline group

EXPERIMENTAL

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

Dry group

EXPERIMENTAL

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

Procedure: Dry group

Interventions

Saline group PROCEDURE

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

Saline group

Dry group PROCEDURE

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

Dry group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim E, Yang SM, Yoon SJ, Bahk JH, Seo JH. The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial. Trials. 2016 Nov 25;17(1):562. doi: 10.1186/s13063-016-1699-0.

  PMID: 27887662 DERIVED

Study Officials

• Jeong-Hwa Seo, Associate professor

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pf.

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 9, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 2, 2017

Record last verified: 2017-06

Locations

KR (1)