Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Equipment
2.2. Patients and Study Design
2.3. Allocation Method
2.4. Outcome Assessment and Evaluation
2.5. Statistical Analysis
3. Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Conventional Group N = 45 | GAGLESS Group N = 45 | p-Value | |
---|---|---|---|
Age, Mean ± SD | 62.3 ± 11.9 | 64.5 ± 12.4 | 0.38 |
First Time, (%) * | 2 (4) | 0 (0) | 0.49 |
SBP, mmHg | 127.8 ± 23.3 | 129.9 ± 19.2 | 0.64 |
DBP, mmHg | 71.4 ± 15.3 | 71.2 ± 13.2 | 0.95 |
PR, /min | 72.5 ± 12.1 | 76.7 ± 18.0 | 0.19 |
SpO2, % | 97.2 ± 1.4 | 96.9 ± 1.8 | 0.48 |
Conventional Group N = 45 | GAGLESS Group N = 45 | p-Value | |
---|---|---|---|
Success Rate, % | 100 | 100 | - |
Adverse Events | None | None | - |
Procedure Time, Seconds | 366.8 ± 220 | 358.3 ± 130 | 0.82 |
VAS1 *, cm | 2.5 ± 2.4 | 2.0 ± 1.9 | 0.24 |
VAS2 **, cm | 2.5 ± 2.4 | 1.7 ± 1.5 | 0.06 |
Differences in SBP, mmHg | 8.0 ± 15.4 | 2.1 ± 15.8 | 0.08 |
Differences in DBP, mmHg | 4.3 ± 9.7 | −0.1 ± 9.2 | 0.03 |
Differences in PR, /min | 3.3 ± 10.3 | 2.8 ± 8.8 | 0.83 |
Differences in SpO2, % | 0.22 ± 1.1 | 0.28 ± 1.5 | 0.81 |
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Ikebuchi, Y.; Matsumoto, K.; Ueda, N.; Yamashita, T.; Kurumi, H.; Onoyama, T.; Takeda, Y.; Yoshida, A.; Kawaguchi, K.; Yashima, K.; et al. Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study. Diagnostics 2021, 11, 538. https://doi.org/10.3390/diagnostics11030538
Ikebuchi Y, Matsumoto K, Ueda N, Yamashita T, Kurumi H, Onoyama T, Takeda Y, Yoshida A, Kawaguchi K, Yashima K, et al. Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study. Diagnostics. 2021; 11(3):538. https://doi.org/10.3390/diagnostics11030538
Chicago/Turabian StyleIkebuchi, Yuichiro, Kazuya Matsumoto, Naoki Ueda, Taro Yamashita, Hiroki Kurumi, Takumi Onoyama, Yohei Takeda, Akira Yoshida, Koichiro Kawaguchi, Kazuo Yashima, and et al. 2021. "Efficacy and Safety of a Novel Mouthpiece for Esophagogastroduodenoscopy: A Multi-Center, Randomized Study" Diagnostics 11, no. 3: 538. https://doi.org/10.3390/diagnostics11030538