Postoperative Sore ThroatNCT05834179
Effect of Colding of Endotracheal Tubes on Sore Throat
A study testing cold endotracheal tube in people with Postoperative Sore Throat, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- cold endotracheal tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 20 Sep 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour
Who cannot join
- Patients with sore throat and lower respiratory tract infection Patients with a history of allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study
Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.
Read the detailed description
The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.
- Conditions
- Postoperative Sore Throat
- Being tested
- cold endotracheal tube
- Keywords
- endotracheal tube, sore throat, dysphagia
- Medical subject headings
- Pharyngitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold endotracheal tubeOther
patients who were intubated with an ETT which kept in the fridge.
| Study group | Role | What they receive |
|---|---|---|
| cold endotracheal tube (ETT) | Experimental | Patients who were intubated with an ETT which kept in the fridge. Receives: Other: cold endotracheal tube |
| Endotracheal tube (ETT) in the normal temperature | No intervention | Patients who were intubated with an ETT which kept in the operation room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of sore throat 1 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Measured: 1 hour after extubation
Secondary outcomes (14)
the severity of sore throat 1 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 1 hour after extubation
the incidence of sore throat 4 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Measured: 4 hour after extubation
the severity of sore throat 4 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 4 hour after extubation
the incidence of sore throat 12 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Measured: 12 hour after extubation
the severity of sore throat 12 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 12 hour after extubation
the incidence of sore throat 24 hour after extubation.
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
Measured: 24 hour after extubation
the severity of sore throat 24 hour after extubation.
Severity will be graded by the patient as 0=null; 1=mild; 2=moderate; 3=severe
Measured: 24 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Measured: 1 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Measured: 4 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Measured: 12 hour after extubation
the incidence of dysphonia
Presence of dysphonia defined as difficulty or pain on speaking (0=no. 1=yes)
Measured: 24 hour after extubation
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Measured: 12 hour after extubation
the incidence of dysphagia
Presence of dysphagia defined as difficulty or pain provoked by swallowing
Measured: 24 hour after extubation
the incidence of postoperative respiratory infection
Presence of respiratory infection symptoms such as cough, sputum, rhinorrhea, sore tongue, myalgia or fever
Measured: 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Catalca, Baskent University
- Investigators
- sibel çatalca, dr., Principal investigator, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834179
- Sponsor's protocol ID
- KA 23-42
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu JH, Paik HS, Ryu HG, Lee H. Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):213-219. doi: 10.1111/aas.13705. Epub 2020 Sep 23.
PubMed 32926423Kim E, Yang SM, Kwak SG, Park S, Bahk JH, Seo JH. Tracheal tubes lubricated with water to reduce sore throat after intubation: A randomized non-inferiority trial. PLoS One. 2018 Oct 4;13(10):e0204846. doi: 10.1371/journal.pone.0204846. eCollection 2018.
PubMed 30286145
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colding of Endotracheal Tubes on Postoperative Sore Throat: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05834179
- Acronym / sponsor ID
- KA 23-42
- Conditions
- Postoperative Sore Throat
- Keywords
- endotracheal tube, sore throat, dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- 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.
Postoperative sore throat (POST) is a common and undesirable postoperative symptom that causes patient dissatisfaction. Cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.
Detailed description
The incidence of postoperative sore throat (POST) has been reported up to 62% following general anaesthesia.It is an undesirable events experienced by patients after general anaesthesia. Various pharmacological agents have been applied to reduce POST, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. However, these agents may have some systemic and local side effects. Therefore, various non-pharmacological applications have been investigated to reduce sore throat. Cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. Although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. Therefore, we hypothesized that colding of endotracheal tube may decrease POST associated with airway inflammation. The aim of this study was to evaluate whether colding of ETT can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. The goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. This study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. Outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold endotracheal tube (ETT) | Experimental | Other: cold endotracheal tubePatients who were intubated with an ETT which kept in the fridge. |
| Endotracheal tube (ETT) in the normal temperature | No intervention | –Patients who were intubated with an ETT which kept in the operation room. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were entubated with an ETT. Those who accept the research Elective surgery Patients in American Society of Anaesthesiologists (ASA) I and II class 18 years and over Mallampati classification I and II Operation time more than 1 hour
Key exclusion criteria (1 listed)
- Patients with sore throat and lower respiratory tract infection Patients with a history of allergies
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 |
|---|---|---|
| cold endotracheal tubepatients who were intubated with an ETT which kept in the fridge. | Other | cold endotracheal tube (ETT) |
Primary outcome
the incidence of sore throat 1 hour after extubation.
Time frame: 1 hour after extubation
Presence of sore throat defined as constant pain, independent of swallowing (0=no. 1=yes)
14 secondary outcomes
the severity of sore throat 1 hour after extubation.
Time frame: 1 hour after extubation
the incidence of sore throat 4 hour after extubation.
Time frame: 4 hour after extubation
the severity of sore throat 4 hour after extubation.
Time frame: 4 hour after extubation
the incidence of sore throat 12 hour after extubation.
Time frame: 12 hour after extubation
the severity of sore throat 12 hour after extubation.
Time frame: 12 hour after extubation
the incidence of sore throat 24 hour after extubation.
Time frame: 24 hour after extubation
the severity of sore throat 24 hour after extubation.
Time frame: 24 hour after extubation
the incidence of dysphonia
Time frame: 1 hour after extubation
the incidence of dysphonia
Time frame: 4 hour after extubation
the incidence of dysphonia
Time frame: 12 hour after extubation
the incidence of dysphonia
Time frame: 24 hour after extubation
the incidence of dysphagia
Time frame: 12 hour after extubation
the incidence of dysphagia
Time frame: 24 hour after extubation
the incidence of postoperative respiratory infection
Time frame: 7 days after operation
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 11 Sep 2025.
- Background: PubMed 32926423Yu JH, Paik HS, Ryu HG, Lee H. Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial. Acta Anaesthesiol Scand. 2021 Feb;65(2):213-219. doi: 10.1111/aas.13705. Epub 2020 Sep 23.
- Background: PubMed 30286145Kim E, Yang SM, Kwak SG, Park S, Bahk JH, Seo JH. Tracheal tubes lubricated with water to reduce sore throat after intubation: A randomized non-inferiority trial. PLoS One. 2018 Oct 4;13(10):e0204846. doi: 10.1371/journal.pone.0204846. eCollection 2018.
- articleLink provided by the sponsor.
- article2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
sibel çatalca, dr. principal investigator
Baskent University Ankara 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 cold endotracheal tube in people with Postoperative Sore Throat, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 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 11 Sep 2025. 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 Turkey (Türkiye). 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?
the incidence of sore throat 1 hour after extubation. (time frame: 1 hour after extubation). 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 NCT05834179, which also lists 2 linked publications.
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 11 Sep 2025.