General AnesthesiaNCT03568279
Jaw-thrust on Postoperative Sore Throat
A study testing Two-handed jaw thrust in people with General Anesthesia, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Two-handed jaw thrust
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2018to 1 Aug 2019
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
Who cannot join
- Difficult airway
- Mallampatti scores greater than 2
- Recent sore throat
- Cervical spine disease
- Recent upper respiratory infection
- Recent analgesics
Show all 9Show fewer
- History of head and neck surgery
- Friable teeth
- Multiple intubation attempts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Two-handed Jaw Thrust on Postoperative Sore Throat
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.
- Conditions
- General Anesthesia
- Being tested
- Two-handed jaw thrust, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-handed jaw thrustProcedure or surgery
The assistant applied two-handed jaw thrust for intubation.
ControlProcedure or surgery
The intubation was done without two-handed jaw thrust.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The attending anesthesiologist provided intubation without two-handed jaw thrust. Receives: Procedure: Control |
| Two-hand | Experimental | The attending anesthesiologist provided intubation with two-handed jaw thrust. Receives: Procedure: Two-handed jaw thrust |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative sore throat for postoperative 24 hour
Measured: At postoperative 24 hour
Secondary outcomes (6)
Number of participants with postoperative sore throat
Measured: At postoperative 2, 4, and 24 hour
Postoperative sore throat scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At postoperative 2, 4, and 24 hour
Number of participants with postoperative hoarseness
Measured: At postoperative 2, 4, and 24 hour
Number of participants with postoperative shivering
Measured: At postoperative 2, 4, and 24 hour
Wound pain scores
Visual analogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At postoperative 2, 4, and 24 hour
Number of participants with jaw discomfort
Measured: At postoperative 2, 4, and 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
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 General AnesthesiaStudies 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568279
- Sponsor's protocol ID
- JTPOST
- Status last verified
- Sep 2018
- First submitted
- 4 Jun 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huh H, Go DY, Cho JE, Park J, Lee J, Kim HC. Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study. J Int Med Res. 2021 Feb;49(2):300060520961237. doi: 10.1177/0300060520961237.
PubMed 33535830
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Two-handed Jaw Thrust on Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT03568279
- Acronym / sponsor ID
- JTPOST
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 26 Jun 2018 (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.
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing endotracheal intubation for general anesthesia.
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 |
|---|---|---|
| Control | Active comparator | Procedure: ControlThe attending anesthesiologist provided intubation without two-handed jaw thrust. |
| Two-hand | Experimental | Procedure: Two-handed jaw thrustThe attending anesthesiologist provided intubation with two-handed jaw thrust. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
Key exclusion criteria (9 listed)
- Difficult airway
- Mallampatti scores greater than 2
- Recent sore throat
- Cervical spine disease
- Recent upper respiratory infection
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 |
|---|---|---|
| Two-handed jaw thrustThe assistant applied two-handed jaw thrust for intubation. | Procedure or surgery | Two-hand |
| ControlThe intubation was done without two-handed jaw thrust. | Procedure or surgery | Control |
Primary outcome
Number of participants with postoperative sore throat for postoperative 24 hour
Time frame: At postoperative 24 hour
6 secondary outcomes
Number of participants with postoperative sore throat
Time frame: At postoperative 2, 4, and 24 hour
Postoperative sore throat scores
Time frame: At postoperative 2, 4, and 24 hour
Number of participants with postoperative hoarseness
Time frame: At postoperative 2, 4, and 24 hour
Number of participants with postoperative shivering
Time frame: At postoperative 2, 4, and 24 hour
Wound pain scores
Time frame: At postoperative 2, 4, and 24 hour
Number of participants with jaw discomfort
Time frame: At postoperative 2, 4, and 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 33535830Huh H, Go DY, Cho JE, Park J, Lee J, Kim HC. Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study. J Int Med Res. 2021 Feb;49(2):300060520961237. doi: 10.1177/0300060520961237.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-handed jaw thrust in people with General Anesthesia, run by Keimyung University Dongsan Medical Center 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 2 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
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?
Number of participants with postoperative sore throat for postoperative 24 hour (time frame: At postoperative 24 hour). 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 NCT03568279, 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 28 Sep 2018; AzTrials last refreshed its copy on 31 Oct 2026.