Trial of a novel mouthpiece in endoscopy

Effectiveness and safety of a novel mouthpiece to prevent aerosol droplets dispersion in upper gastrointestinal endoscopy : a randomized controlled trial - SUPER DRY trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1022220019

Enrollment

200

Registered

2022-08-27

Start date

2022-02-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contribution to the droplet infection measures and reduction of the stress in endoscopy

Interventions

The patients are divided in two at random by a group receiving EGD by the method that used a surgical-style mask together to a conventional mouthpiece and a group receiving EGD using a new model mouth

D009064

mouthpiece

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients who upper gastrointestinal endoscopy was planned in our hospital and agreed to this study

Exclusion criteria

Exclusion criteria: The patients who the upper gastrointestinal endoscopy was planned under the sedation The patients who undergoes the oral upper gastrointestinal endoscopy for the first time

Design outcomes

Primary

Measure	Time frame
We inspect the effectiveness of the novel mouthpiece by comparison of the ratio of person of satisfaction between the patients using the novel mouthpiece and the patients who used a surgical-style mask together to a conventional mouthpiece. We define the patient who evaluated the high rank first or the second of five phases for both 4 questions of the question vote as a person of satisfaction. The primary outcome is comparison of the ratio of a person of satisfaction for the whole between two groups.	—

Measure

Time frame

We inspect the effectiveness of the novel mouthpiece by comparison of the ratio of person of satisfaction between the patients using the novel mouthpiece and the patients who used a surgical-style mask together to a conventional mouthpiece. We define the patient who evaluated the high rank first or the second of five phases for both 4 questions of the question vote as a person of satisfaction. The primary outcome is comparison of the ratio of a person of satisfaction for the whole between two groups.

—

Secondary

Measure	Time frame
We inspect the safety of the novel mouthpiece by comparison the ratio of person of hypoxidosis blood symptom between the patients using the new mouthpiece and the patients who used a surgical-style mask together to a conventional mouthpiece. We define when SpO2 is as follows 93% even once as hypoxidosis. We compare the ratio of person with hypoxemia for the whole between two groups. In addition, as supplement of primary outcome, we compare the ratio for the whole of the patients who evaluated the high rank first or the second of five phases in each four questions of the question vote.	—

Measure

Time frame

We inspect the safety of the novel mouthpiece by comparison the ratio of person of hypoxidosis blood symptom between the patients using the new mouthpiece and the patients who used a surgical-style mask together to a conventional mouthpiece. We define when SpO2 is as follows 93% even once as hypoxidosis. We compare the ratio of person with hypoxemia for the whole between two groups. In addition, as supplement of primary outcome, we compare the ratio for the whole of the patients who evaluated the high rank first or the second of five phases in each four questions of the question vote.

—

Contacts

Public ContactRyoichiro Kobashi

Department of Endoscopy, Fukushima Medical University Hospital

rkobashi@fmu.ac.jp+81-24-547-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026