Arthroplasty, Replacement, HipNCT04247360
Effect of Cuff Pressure During Operation on Postoperative Sore Throat
A study testing cuff pressure in people with Arthroplasty, Replacement, Hip, run by Keimyung University Dongsan Medical Center.
Trial summary
When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- cuff pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing total hip replacement arthroplasty that require general anesthesia
Who cannot join
- a patient who disagrees with the study
- tracheal stenosis
- operation time > 3 hours or < 1 hour 30 minutes
- difficult airway
- drug abuse, alcoholism
About this study
When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.
Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.
Read the detailed description
Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.
l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O
After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- cuff pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff pressureDevice
maintaining cuff pressure according the groups
| Study group | Role | What they receive |
|---|---|---|
| cuff pressure with 20cmH2O | Other | continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery Receives: Device: cuff pressure |
| cuff pressure with 30cmH2O | Other | continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery Receives: Device: cuff pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sore throat
Number of participants with postoperative sore throat for postoperative 24 hours
Measured: At postoperative 24 hours
Secondary outcomes (3)
postoperative hoarseness
Number of participants with postoperative hoarseness for postoperative 24 hours
Measured: At postoperative 24 hours
nausea
Number of participants with postoperative nausea for postoperative 24 hours
Measured: At postoperative 24 hours
Requirements of analgesics
Number of participants with analgesics use for postoperative 24 hours
Measured: At postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwon Lee, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247360
- Sponsor's protocol ID
- 2018-09-030
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cuff Pressure During Operation on Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT04247360
- Acronym / sponsor ID
- 2018-09-030
- Conditions
- Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Jan 2020 (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.
When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.
Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.
Detailed description
Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.
l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O
After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cuff pressure with 20cmH2O | Other | Device: cuff pressurecontinuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery |
| cuff pressure with 30cmH2O | Other | Device: cuff pressurecontinuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing total hip replacement arthroplasty that require general anesthesia
Key exclusion criteria (5 listed)
- a patient who disagrees with the study
- tracheal stenosis
- operation time > 3 hours or < 1 hour 30 minutes
- difficult airway
- drug abuse, alcoholism
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 |
|---|---|---|
| cuff pressuremaintaining cuff pressure according the groups | Device | cuff pressure with 20cmH2O, cuff pressure with 30cmH2O |
Primary outcome
postoperative sore throat
Time frame: At postoperative 24 hours
Number of participants with postoperative sore throat for postoperative 24 hours
3 secondary outcomes
postoperative hoarseness
Time frame: At postoperative 24 hours
nausea
Time frame: At postoperative 24 hours
Requirements of analgesics
Time frame: At postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cuff pressure in people with Arthroplasty, Replacement, Hip, run by Keimyung University Dongsan Medical Center.
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 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
postoperative sore throat (time frame: At postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.