高齢者における食後低血圧と導入後低血圧の相関。
高齢者における食後低血圧と導入後低血圧などの周術期の有害事象との相関：前向き観察研究。
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
調査の概要
詳細な説明
With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100730
- Peking Union Medical College Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital
説明
Inclusion Criteria:
- Elderly patients (≥ 65 years old）;
- Patients with American Society of Anesthesiologists(ASA) grade I-III;
- Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
- Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
Exclusion Criteria:
- Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
- Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
- Patients with chronic kidney disease requiring dietary restrictions or dialysis.
- Patients with Parkinson's disease or other conditions causing tremors.
- Patients with problems related to oral food ingestion or those requiring enteral nutrition.
- Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
- Patients unable to remain in a supine position for at least 2 hours.
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
Postprandial hypotension group
Patients who have a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of the lunch |
|
No postprandial hypotension group
Patients who do not meet the postprandial hypotension criteria within 2 hours of the lunch |
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 |
|---|---|---|
|
Post-induction hypotension
時間枠：Within 20 minutes after induction or before incision.
|
which is defined as systolic blood pressure (SBP) <90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision. |
Within 20 minutes after induction or before incision.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative complications
時間枠：Within 30 days after surgery
|
We will use the Clavien-Dindo system to grade postoperative complications. |
Within 30 days after surgery
|
|
early intraoperative hypotension （eIOH）
時間枠：within the first 30 minutes after the start of surgery
|
which is defined asa systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a decrease of more than 30% from baseline |
within the first 30 minutes after the start of surgery
|
|
mortality within 30 days after surgery
時間枠：within 30 days after surgery
|
we will assess the mortality by postoperative follow-up |
within 30 days after surgery
|
|
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)
時間枠：within 180 days after surgery
|
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be employed to evaluate postoperative functional health status. The 12-item version yields a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer health outcomes. |
within 180 days after surgery
|
協力者と研究者
捜査官
- 主任研究者：Li Xu, M.D.、Peking Union Medical College Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- I-22PJ008
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?
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