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UMIN-CTR 臨床試験登録情報の閲覧 |
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 UMIN-CTR ホーム |
用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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| 利用者名： | UMIN ID： |
| 試験進捗状況 | 一般募集中/Open public recruiting |
| UMIN試験ID | UMIN000030918 |
| 受付番号 | R000035305 |
| 試験名 | 遠隔虚血プレコンディショニングの術後呼吸機能に及ぼす影響：メタ解析と試験逐次解析 |
| 一般公開日（本登録希望日） | 2018/08/01 |
| 最終更新日 | 2018/03/14 |
| 基本情報/Basic information | |||
| 試験名/Official scientific title of the study | 遠隔虚血プレコンディショニングの術後呼吸機能に及ぼす影響：メタ解析と試験逐次解析 | Effect of remote ischemic preconditioning in improving postoperative pulmonary function in adult patients: A meta-analysis with trial sequential analysis | |
| 試験簡略名/Title of the study (Brief title) | 遠隔虚血プレコンディショニングの術後呼吸機能に及ぼす影響 | Effect of remote ischemic preconditioning on postoperative pulmonary function | |
| 試験実施地域/Region |
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| 対象疾患/Condition | ||||
| 対象疾患名/Condition | 全身麻酔を受ける患者 | Patients who undergo general anesthesia | ||
| 疾患区分1/Classification by specialty |
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| 疾患区分2/Classification by malignancy | 悪性腫瘍以外/Others | |||
| ゲノム情報の取扱い/Genomic information | いいえ/NO | |||
| 目的/Objectives | ||
| 目的1/Narrative objectives1 | 遠隔虚血プレコンディショニングによる術後呼吸機能に及ぼす影響を検討する． | Effect of remote ischemic preconditioning on postoperative pulmonary function was controversial. The aim of this study is to investigate the effect of remote ischemic preconditioning on postoperative pulmonary function. |
| 目的2/Basic objectives2 | 有効性/Efficacy | |
| 目的2 -その他詳細/Basic objectives -Others | ||
| 試験の性質1/Trial characteristics_1 | ||
| 試験の性質2/Trial characteristics_2 | ||
| 試験のフェーズ/Developmental phase | ||
| 評価/Assessment | ||
| 主要アウトカム評価項目/Primary outcomes | 術後24時間でのPaO2/FIO2比 | The primary outcome of the present meta-analysis is the PaO2/FIO2 ratio 24 hours after surgery. |
| 副次アウトカム評価項目/Key secondary outcomes | The secondary outcomes are the incidence of pulmonary complication, postoperative inflammation, acute kidney injury, cardiac function. | |
| 基本事項/Base | ||
| 試験の種類/Study type | その他・メタアナリシス等/Others,meta-analysis etc | |
| 試験デザイン/Study design | ||
| 基本デザイン/Basic design | ||
| ランダム化/Randomization | ||
| ランダム化の単位/Randomization unit | ||
| ブラインド化/Blinding | ||
| コントロール/Control | ||
| 層別化/Stratification | ||
| 動的割付/Dynamic allocation | ||
| 試験実施施設の考慮/Institution consideration | ||
| ブロック化/Blocking | ||
| 割付コードを知る方法/Concealment | ||
| 介入/Intervention | ||
| 群数/No. of arms | ||
| 介入の目的/Purpose of intervention | ||
| 介入の種類/Type of intervention | ||
| 介入1/Interventions/Control_1 | ||
| 介入2/Interventions/Control_2 | ||
| 介入3/Interventions/Control_3 | ||
| 介入4/Interventions/Control_4 | ||
| 介入5/Interventions/Control_5 | ||
| 介入6/Interventions/Control_6 | ||
| 介入7/Interventions/Control_7 | ||
| 介入8/Interventions/Control_8 | ||
| 介入9/Interventions/Control_9 | ||
| 介入10/Interventions/Control_10 | ||
| 適格性/Eligibility | |||||
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender | 男女両方/Male and Female | ||||
| 選択基準/Key inclusion criteria | 遠隔虚血プレコンディショニングによる術後呼吸機能の変化を検討したランダム化比較試験 | We search for all randomized controlled trials that tested the effect of remote ischemic preconditioning on postoperative pulmonary function. | |||
| 除外基準/Key exclusion criteria | 症例報告やレター，システマティックレビューは除外する．また，動物実験も除外する． | We exclude data case reports, comments or letters to the editor, reviews, and animal studies. Eligibility is not restricted by language, type of surgery, anesthetic technique, or patient age. | |||
| 目標参加者数/Target sample size | 0 | ||||
| 責任研究者/Research contact person | ||
| 責任研究者名/Name of lead principal investigator | 水原敬洋 | Takahiro Mihara |
| 所属組織/Organization | 横浜市立大学附属病院 | Yokohama City University Hospital |
| 所属部署/Division name | 麻酔科 | Department of Anesthesiology |
| 住所/Address | 横浜市金沢区福浦3-9 | 3-9, Fukuura, Kanazawa-ku, Yokohama city |
| 電話/TEL | 045-787-2800 | |
| Email/Email | miharaxxxtotoro@yahoo.co.jp | |
| 試験問い合わせ窓口/Public contact | ||
| 試験問い合わせ窓口担当者名/Name of contact person | 水原敬洋 | Takahiro Mihara |
| 組織名/Organization | 横浜市立大学附属病院 | Yokohama City University Hospital |
| 部署名/Division name | 麻酔科 | Department of Anesthesiology |
| 住所/Address | 横浜市金沢区福浦3-9 | 3-9, Fukuura, Kanazawa-ku, Yokohama city |
| 電話/TEL | 0457872800 | |
| 試験のホームページURL/Homepage URL | ||
| Email/Email | miharaxxxtotoro@yahoo.co.jp | |
| 実施責任組織/Sponsor | ||
| 機関名/Institute | その他 | Yokohama City University Hospital |
| 機関名/Institute （機関選択不可の場合） |
横浜市立大学附属病院 | |
| 部署名/Department | ||
| 研究費提供組織/Funding Source | ||
| 機関名/Organization | 無し | None |
| 機関名/Organization （機関選択不可の場合） |
None | |
| 組織名/Division | ||
| 組織の区分/Category of Funding Organization | その他/Other | |
| 研究費拠出国/Nationality of Funding Organization | ||
| その他の関連組織/Other related organizations | ||
| 共同実施組織/Co-sponsor | ||
| その他の研究費提供組織/Name of secondary funｄer(s) | ||
| 他機関から発行された試験ID/Secondary IDs | ||
| 他機関から発行された試験ID/Secondary IDs | いいえ/NO | |
| 試験ID1/Study ID_1 | ||
| ID発行機関1/Org. issuing International ID_1 | ||
| 試験ID2/Study ID_2 | ||
| ID発行機関2/Org. issuing International ID_2 | ||
| 治験届/IND to MHLW | ||
| 試験実施施設/Institutions | ||
| 試験実施施設名称/Institutions | ||
| その他の管理情報/Other administrative information | ||||||||
| 一般公開日（本登録希望日）/Date of disclosure of the study information |
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| 試験進捗状況/Progress | ||||||||
| 試験進捗状況/Recruitment status | 一般募集中/Open public recruiting | |||||||
| プロトコル確定日/Date of protocol fixation |
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| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| フォロー終了(予定)日/Last follow-up date | ||||||||
| 入力終了(予定)日/Date of closure to data entry | ||||||||
| データ固定（予定）日/Date trial data considered complete | ||||||||
| 解析終了(予定)日/Date analysis concluded | ||||||||
| 関連情報/Related information | ||
| プロトコル掲載URL/URL releasing protocol | ||
| 試験結果の公開状況/Publication of results | 未公表/Unpublished | |
| 結果掲載URL/URL releasing results | ||
| 主な結果/Results | ||
| その他関連情報/Other related information | 本研究の詳細は添付の研究計画書参照． | The study protocol is attached in this pre-registration or can be seen at http://www-user.yokohama-cu.ac.jp/~masuika/protocol/
MEDLINE, CENTRAL, Embase, and Web of Science are searched. Further, we conduct a search of clinicaltrials.gov and the UMIN Clinical Trials Registry. Two authors independently scan the titles and abstracts of reports identified by the variety of search strategies described above. The articles that meet the inclusion criteria are assessed separately by two authors, and any discrepancies are resolved through discussion. Continuous data are summarized using mean difference with a 95% confidence interval. Dichotomous data are summarized using risk ratio with a 95% CI. Heterogeneity is quantified with the I2 statistic. We consider that significant heterogeneity existed when the I2 statistic exceeded 50%. We plan to conduct subgroup analysis according to the following predefined factors when the I2 statistic exceeded 50%: type of anesthesia, type of surgery, or patients age. We use the random effect model to combine the results. For our primary outcome, trial sequential analysis are performed to correct for random error and repetitive testing of accumulating and sparse data. Risk of type 1 error is maintained at 5% with a power of 90%. The mean difference of the PaO2/FIO2 ratio 24 hours after surgery of 50 was considered clinically meaningful. |
| 管理情報/Management information | ||||||||
| 登録日時/Registered date |
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| 最終更新日/Last modified on |
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| 閲覧ページへのリンク/Link to view the page | |
| URL(日本語) | https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035305 |
| URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035305 |
| 研究計画書 | |
| 登録日時 | ファイル名 |
| 研究症例データ仕様書 | |
| 登録日時 | ファイル名 |
| 研究症例データ | |
| 登録日時 | ファイル名 |
