Gallbladder DiseasesNCT04409652
Head Position on Preventing Emergence Cough
A study testing Head on bed and Head on pillow in people with Gallbladder Diseases, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation. Read more about this study
- Who is it for?
- Ages 19 to 85 years, men only
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- Head on bed and Head on pillow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2020to 31 Dec 2022
- 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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operation schedule of laparoscopic cholecystectomy
- Must be performed under general anesthesia
Who cannot join
- BMI > 30 kg/m2
- Respiratory infection
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon
About this study
Official title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.
Read the detailed description
During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.
- Conditions
- Gallbladder Diseases
- Being tested
- Head on bed, Head on pillow
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head on bedProcedure or surgery
During emergence, head is kept on bed without pillow.
Head on pillowProcedure or surgery
During emergence, head is kept on pillow.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The endotracheal extubation is performed in head on bed without pillow. Receives: Procedure: Head on bed |
| Head elevation group | Active comparator | The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) . Receives: Procedure: Head on pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of cough
0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough
Measured: during extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start2 Jun 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409652
- Sponsor's protocol ID
- AJIRB-MED-OBS-20-055
- Status last verified
- Nov 2023
- First submitted
- 25 May 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
- ClinicalTrials.gov ID
- NCT04409652
- Acronym / sponsor ID
- AJIRB-MED-OBS-20-055
- Conditions
- Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Jun 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.
The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.
Detailed description
During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: Head on bedThe endotracheal extubation is performed in head on bed without pillow. |
| Head elevation group | Active comparator | Procedure: Head on pillowThe endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) . |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operation schedule of laparoscopic cholecystectomy
- Must be performed under general anesthesia
Key exclusion criteria (3 listed)
- BMI > 30 kg/m2
- Respiratory infection
- Uncontrolled hypertension
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 |
|---|---|---|
| Head on bedDuring emergence, head is kept on bed without pillow. | Procedure or surgery | Control group |
| Head on pillowDuring emergence, head is kept on pillow. | Procedure or surgery | Head elevation group |
Primary outcome
The severity of cough
Time frame: during extubation
0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough
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 9 Nov 2023.
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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 Head on bed and Head on pillow in people with Gallbladder Diseases, run by Ajou University School of Medicine 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 3 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 9 Nov 2023. 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. Some participants in this study may receive a placebo. 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 severity of cough (time frame: during extubation). 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 9 Nov 2023.