Cotamination on Face ShieldNCT04329013
Position of EGD in Droplet Spreading
A study testing Left lateral Position during intervention and Prone Position during intervention in people with Cotamination on Face Shield, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cotamination on Face Shield
- What is being tested?
- Left lateral Position during intervention and Prone Position during intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2020to 30 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have the indication for upper gastrointestinal endoscopy
Who cannot join
- Cannot be in prone position
- The endoscopist deny the assigned position in any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial
The association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading of patients in left lateral and prone position during EGD.
- Conditions
- Cotamination on Face Shield
- Being tested
- Left lateral Position during intervention, Prone Position during intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left lateral Position during interventionOther
Left lateral position during EGD
Prone Position during interventionOther
Prone position during EGD
| Study group | Role | What they receive |
|---|---|---|
| Left lateral position | Active comparator | The patient will be in left lateral position during EGD Receives: Other: Left lateral Position during intervention |
| Prone position | Experimental | The patient will be in prone position during EGD Receives: Other: Prone Position during intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of adenosine triphosphate (ATP) on face shield of endoscopist
Measuring the ATP on face shield of endoscopist by using ATP luminometer. It is measured in relative light unit (RLU). The level of ATP is concordant with the level of bacteria on that measuring object.
Measured: immediately following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cotamination on Face ShieldStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329013
- Sponsor's protocol ID
- RP017
- Status last verified
- Dec 2020
- First submitted
- 28 Mar 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not plan for data sharing due to the privacy of each patient.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial
- ClinicalTrials.gov ID
- NCT04329013
- Acronym / sponsor ID
- RP017
- Conditions
- Cotamination on Face Shield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 1 Apr 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 association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading of patients in left lateral and prone position during EGD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.
| Arm | Type | Receives |
|---|---|---|
| Left lateral position | Active comparator | Other: Left lateral Position during interventionThe patient will be in left lateral position during EGD |
| Prone position | Experimental | Other: Prone Position during interventionThe patient will be in prone position during EGD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have the indication for upper gastrointestinal endoscopy
Key exclusion criteria (2 listed)
- Cannot be in prone position
- The endoscopist deny the assigned position in any reason.
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 |
|---|---|---|
| Left lateral Position during interventionLeft lateral position during EGD | Other | Left lateral position |
| Prone Position during interventionProne position during EGD | Other | Prone position |
Primary outcome
The level of adenosine triphosphate (ATP) on face shield of endoscopist
Time frame: immediately following the procedure
Measuring the ATP on face shield of endoscopist by using ATP luminometer. It is measured in relative light unit (RLU). The level of ATP is concordant with the level of bacteria on that measuring object.
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 7 Dec 2020.
- Individual participant dataSharing planned: No. Do not plan for data sharing due to the privacy of each patient.
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 Left lateral Position during intervention and Prone Position during intervention in people with Cotamination on Face Shield, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 2 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 7 Dec 2020. 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 Thailand. 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 level of adenosine triphosphate (ATP) on face shield of endoscopist (time frame: immediately following the procedure). 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 7 Dec 2020.