Back to resultsEffect of Saline Lubrication on Post-intubation Complications (Lubrication)
Primary Purpose
Postoperative Sore Throat
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Saline group
Dry group
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Sore Throat
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Saline group
Dry group
Arm Description
In the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction.
In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.
Outcomes
Primary Outcome Measures
incidence of postoperative sore throat (POST)
ask patients whether they have sore throat after surgery
Secondary Outcome Measures
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
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.
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)
Full Information
NCT ID
NCT02492646
First Posted
July 1, 2015
Last Updated
June 1, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02492646
Brief Title
Effect of Saline Lubrication on Post-intubation Complications
Acronym
Lubrication
Official Title
Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline group
Arm Type
Experimental
Arm Description
In the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction.
Arm Title
Dry group
Arm Type
Experimental
Arm Description
In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.
Intervention Type
Procedure
Intervention Name(s)
Saline group
Intervention Description
After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.
Intervention Type
Procedure
Intervention Name(s)
Dry group
Intervention Description
After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.
Primary Outcome Measure Information:
Title
incidence of postoperative sore throat (POST)
Description
ask patients whether they have sore throat after surgery
Time Frame
until one day after surgery
Secondary Outcome Measure Information:
Title
Oropharyngeal injury
Description
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
Time Frame
2 hours and 24 hours after surgery
Title
respiratory symptoms
Description
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.
Time Frame
1 week after the surgery
Title
severity of postoperative sore throat (POST)
Description
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)
Time Frame
When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Hwa Seo, Associate professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27887662
Citation
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.
Results Reference
derived
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Effect of Saline Lubrication on Post-intubation Complications
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