Lung SurgeryNCT03331809
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion
A study testing Two-handed jaw thrust and Conventional intubation in people with Lung Surgery, 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 double-lumen endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Surgery
- What is being tested?
- Two-handed jaw thrust and Conventional intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2017to 2 May 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Patients scheduled for double-lumen endotracheal intubation
Who cannot join
- Difficult airway
- Mallampatti scores greater than 3
- Recent sore throat
- Cervical spine disease
- History of head and neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Two-handed Jaw Thrust on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
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 double-lumen endotracheal intubation.
- Conditions
- Lung Surgery
- Being tested
- Two-handed jaw thrust, Conventional intubation
- Keywords
- intubation, pharyngitis
- Medical subject headings
- Pharyngitis
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 when intubating with double-lumen tube endotracheal tube.
Conventional intubationProcedure or surgery
The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Procedure: Conventional intubation |
| Two-hand | Experimental | Not described 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 h
Measured: At 24 hr
Secondary outcomes (6)
Number of participants with postoperative sore throat
Measured: At 1, 6, and 24 hr
Postoperative sore throat scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 1, 6, and 24 hr
Number of participants with postoperative hoarseness
Measured: At 1, 6, and 24 hr
Number of participants with postoperative shivering
Measured: At 1, 6, and 24 hr
Wound pain scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 1, 6, and 24 hr
Jaw discomfort scores
Visual anlogue scales will be used (10: most imaginable pain, 0: no pain).
Measured: At 1, 6, and 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start11 Dec 2017
- Primary completion1 May 2018
- Study completion2 May 2018
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 Lung SurgeryStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331809
- Sponsor's protocol ID
- 2017-11-002
- Status last verified
- Jun 2018
- First submitted
- 1 Nov 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
PubMed 31860598
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. 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 in Patients Undergoing Double-lumen Endobronchial Tube Insertion
- ClinicalTrials.gov ID
- NCT03331809
- Acronym / sponsor ID
- 2017-11-002
- Conditions
- Lung Surgery
- Keywords
- intubation, pharyngitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 6 Nov 2017 (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 double-lumen endotracheal intubation.
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: Conventional intubation |
| Two-hand | Experimental | Procedure: Two-handed jaw thrust |
Who may qualify
- Ages
- 18 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 double-lumen endotracheal intubation
Key exclusion criteria (5 listed)
- Difficult airway
- Mallampatti scores greater than 3
- Recent sore throat
- Cervical spine disease
- History of head and neck surgery
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 when intubating with double-lumen tube endotracheal tube. | Procedure or surgery | Two-hand |
| Conventional intubationThe attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust. | Procedure or surgery | Control |
Primary outcome
Number of participants with postoperative sore throat for postoperative 24 h
Time frame: At 24 hr
6 secondary outcomes
Number of participants with postoperative sore throat
Time frame: At 1, 6, and 24 hr
Postoperative sore throat scores
Time frame: At 1, 6, and 24 hr
Number of participants with postoperative hoarseness
Time frame: At 1, 6, and 24 hr
Number of participants with postoperative shivering
Time frame: At 1, 6, and 24 hr
Wound pain scores
Time frame: At 1, 6, and 24 hr
Jaw discomfort scores
Time frame: At 1, 6, and 24 hr
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 18 Mar 2019.
- Derived from this study: PubMed 31860598Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
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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 and Conventional intubation in people with Lung Surgery, 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 5 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 18 Mar 2019. 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?
Number of participants with postoperative sore throat for postoperative 24 h (time frame: At 24 hr). 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 NCT03331809, 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 18 Mar 2019.