The Purpose of This Clinical Trial is to Evaluate the Accuracy of Blood Pressure Measurement of HiCardi M350 Compared to Blood Pressure Measured by Auscultatory Sphygmomanometer in Adult Volunteers (Including Those Meeting Blood Pressure Distribution Requirements) in Accordance With ISO 81060-2:2018
A Prospective, Single-center, Single-arm, Pivotal Clinical Trial to Evaluate the Accuracy of Blood Pressure Measurements From the HiCardi M350(Patient Monitor) in Comparison With Those Measured Using an Auscultatory Sphygmomanometer
This prospective, single-center, single-arm pivotal clinical trial is designed to evaluate the accuracy of blood pressure measurements obtained using the HiCardi M350 patient monitor compared with measurements obtained using an auscultatory sphygmomanometer.
The study will enroll adult volunteers aged 19 years or older, including participants needed to satisfy the blood pressure distribution requirements of ISO 81060-2:2018. The planned enrollment is 100 participants, considering the ISO 81060-2:2018 minimum requirement of 85 participants and an estimated dropout rate of approximately 15%. The study is also designed to obtain at least 255 valid paired blood pressure values.
After written informed consent, participants will undergo screening assessments, including demographics, vital signs, medical and surgical history, prior and concomitant medications, pregnancy testing for women of childbearing potential, bilateral arm circumference measurement, eligibility assessment, and adverse event assessment. On the blood pressure test day, eligibility will be reconfirmed, an enrollment number will be assigned, HiCardi M350 calibration will be performed, and blood pressure measurements will be obtained using both HiCardi M350 and the reference auscultatory method.
The primary effectiveness endpoint is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference sphygmomanometer under resting conditions. Accuracy will be evaluated according to ISO 81060-2:2018 using Criteria 1 and Criteria 2. Safety will be evaluated based on adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated adverse device effects, and device deficiencies.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Min Dong Sung, Professor
- 電話番号：+82-10-6554-0827
- メール：MDSUNG@yuhs.ac
研究場所
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Seoul
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Seoul、Seoul、韓国、03722
- 募集
- Severance Hospital
-
コンタクト：
- Min Dong Sung, Professor
- 電話番号：+82-10-6554-0827
- メール：MDSUNG@yuhs.ac
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 19 years or older.
- Individuals who visit Severance Hospital and voluntarily provide written informed consent after receiving and understanding sufficient explanation of the study.
- Individuals with hypertension-range blood pressure may be included to meet the blood pressure distribution requirements. Participants receiving antihypertensive medication may be included only if the type and dose of medication have remained stable for at least 4 weeks before screening. Individuals with dose changes, medication additions, or medication discontinuation within 4 weeks before screening will be excluded.
Exclusion Criteria:
- Individuals in whom Korotkoff phase V cannot be clearly identified during auscultatory blood pressure measurement.
- Individuals for whom blood pressure measurement is difficult or expected to be difficult.
- Individuals with bilateral arm circumference greater than 42 cm.
- Pregnant women.
- Individuals currently participating in another clinical trial or who have participated in another clinical trial within 30 days before the screening date.
- Individuals judged by the investigator to be inappropriate for participation in the clinical trial.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HiCardi M350
Participants will undergo blood pressure measurement using the investigational device, HiCardi M350, and the reference auscultatory sphygmomanometer.
HiCardi M350 will be attached and calibrated according to the predefined procedure.
Systolic and diastolic blood pressure values measured by HiCardi M350 will be compared with reference values measured by two independent observers using the auscultatory method.
|
HiCardi M350 is a wearable patient monitoring device used to measure systolic and diastolic blood pressure.
In this study, the device will be attached to each participant and calibrated according to the predefined procedure.
Blood pressure values measured by HiCardi M350 will be compared with reference values obtained using an auscultatory sphygmomanometer and mechanical stethoscope by two independent observers.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference between systolic and diastolic blood pressure measurements obtained using HiCardi M350 and a reference auscultatory sphygmomanometer
時間枠：After completion of all participants' data collection (within approximately 7 months of enrollment period)
|
The primary outcome is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference auscultatory sphygmomanometer under resting conditions.
Accuracy will be assessed separately for systolic and diastolic blood pressure according to ISO 81060-2:2018 Criteria 1 and Criteria 2.
|
After completion of all participants' data collection (within approximately 7 months of enrollment period)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1-2026-0008
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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