Trial of a novel mouthpiece in endoscopy

JRCT ID: jRCT1022220019

Registered date:27/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: contribution to the droplet infection measures and reduction of the stress in endoscopy
• Date of first enrollment: 08/02/2022
• Target sample size: 200
• Study type: Interventional
• Intervention(s): 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 mouthpiece.

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: The patients who upper gastrointestinal endoscopy was planned in our hospital and agreed to this study

Exclude 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

Related Information

• Primary Sponsor: Hikichi Takuto
• Source(s) of Monetary Support: KSM CO.,LTD