Postoperative Sore ThroatLubricationNCT02492646
Effect of Saline Lubrication on Post-intubation Complications
A study testing Saline group and Dry group in people with Postoperative Sore Throat, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Saline group and Dry group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation
Who cannot join
- 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
Show all 9Show fewer
- symptoms of sore throat or upper respiratory tract infection
- expected to place nasogastric tube during perioperative period
- requiring nasotracheal intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
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
- Being tested
- Saline group, Dry group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline groupProcedure or surgery
After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.
Dry groupProcedure or surgery
After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Saline group |
| Dry group | Experimental | In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation. Receives: Procedure: Dry group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative sore throat (POST)
ask patients whether they have sore throat after surgery
Measured: until one day after surgery
Secondary outcomes (3)
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
Measured: 2 hours and 24 hours after surgery
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.
Measured: 1 week after the surgery
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)
Measured: When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
- Investigators
- Jeong-Hwa Seo, Associate professor, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492646
- Sponsor's protocol ID
- JHSeo_Saline
- Acronym
- Lubrication
- Status last verified
- Jun 2017
- First submitted
- 1 Jul 2015
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27887662
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02492646
- Acronym / sponsor ID
- Lubrication / JHSeo_Saline
- Conditions
- Postoperative Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | Experimental | Procedure: Saline groupIn the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction. |
| Dry group | Experimental | Procedure: Dry groupIn the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline groupAfter anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation. | Procedure or surgery | Saline group |
| Dry groupAfter anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline. | Procedure or surgery | Dry group |
Primary outcome
incidence of postoperative sore throat (POST)
Time frame: until one day after surgery
ask patients whether they have sore throat after surgery
3 secondary outcomes
Oropharyngeal injury
Time frame: 2 hours and 24 hours after surgery
respiratory symptoms
Time frame: 1 week after the surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Derived from this study: PubMed 27887662Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Hwa Seo, Associate professor study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline group and Dry group in people with Postoperative Sore Throat, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative sore throat (POST) (time frame: until one day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.