Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing
2026年8月17日 更新者：Stephen Warner、The University of Texas Health Science Center, Houston
Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing: A Feasibility Study
The purpose of this study is to measure intraoperative embolic burden during prophylactic intramedullary nailing of impending femur fractures in patients treated with versus without venting, to find the association between embolic burden and intraoperative physiologic changes, measured using standard anesthesia monitors and charted data, to measure Immediate and short-term cardiopulmonary outcomes assessed during hospitalization and to assess procedure-related complications associated with venting
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Stephen Warner, MD, PhD
- 電話番号：(713) 486-6998
- メール：Stephen.J.Warner@uth.tmc.edu
研究連絡先のバックアップ
- 名前：Collyn O'Quin
- 電話番号：(713) 486-6536
- メール：Collyn.OQuin@uth.tmc.edu
研究場所
-
-
Texas
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Houston、Texas、アメリカ、77030
- The University of Texas Health Science Center at Houston
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コンタクト：
- Collyn O'Quin
- 電話番号：(713) 486-6536
- メール：Collyn.OQuin@uth.tmc.edu
-
コンタクト：
- Stephen J Warner, MD, PhD
- 電話番号：(713) 486-6998
- メール：Stephen.J.Warner@uth.tmc.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Diagnosis of an impending femur fracture requiring prophylactic intramedullary fixation
Impending fracture secondary to a pathologic process, including:
- Long-term bisphosphonate use, or
- Oncologic disease without radiographic evidence of cortical disruption
- Ability to provide informed consent
Exclusion Criteria:
- Inability to obtain adequate intraoperative transthoracic echocardiography (TTE) imaging windows for visualization of right-sided cardiac structures
- Inability to tolerate or safely undergo TTE monitoring per anesthesia determination
- Any intraoperative technical limitation preventing reliable echocardiographic data acquisition
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：介入グループ
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Participants will undergo femoral venting prior to prophylactic intramedullary fixation .
Participants will undergo prophylactic intramedullary fixation
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アクティブコンパレータ：対照群
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Participants will undergo prophylactic intramedullary fixation
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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 |
|---|---|---|
|
Change in Embolic burden as assessed by intraoperative transthoracic echocardiography (TTE)
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
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Embolic burden is defined as the presence, frequency, and severity (graded semi-quantitatively) of echogenic embolic events within the right atrium, right ventricle, and pulmonary artery outflow tract.
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baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in Embolic Burden as assessed by change in Heart rate
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
|
Change in Embolic Burden as assessed by change in Mean arterial pressure
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 after start of surgery)
|
|
Change in Embolic Burden as assessed by change in oxygen saturation
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
|
Change in Embolic Burden as assessed by change in end-tidal carbon dioxide
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
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|
Embolic Burden as assessed by change in vasopressor requirement
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
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baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
|
Embolic Burden as assessed by change in arterial blood gas parameters (PaO₂, partial pressure of carbon dioxide in arterial blood(PaCO₂), A-a gradient when obtained as part of clinical care).
時間枠：baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
baseline (prior to canal instrumentation), during canal preparation/reaming, during nail insertion, and immediately post-procedure(about 1 to 2 hours after start of surgery)
|
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Need for postoperative vasopressor or respiratory support
時間枠：Intraoperative through hospital discharge (about 2 to 3 days after surgery)
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Intraoperative through hospital discharge (about 2 to 3 days after surgery)
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Number of participants that need ICU admission
時間枠：at hospital discharge (about 2 to 3 days after surgery)
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at hospital discharge (about 2 to 3 days after surgery)
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Length of hospital stay
時間枠：at hospital discharge (about 2 to 3 days after surgery)
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at hospital discharge (about 2 to 3 days after surgery)
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Number of participants with postoperative hematoma
時間枠：During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with surgical site infection
時間枠：During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with wound complications
時間枠：During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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Number of participants with peri-implant fracture or iatrogenic fracture
時間枠：During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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During hospitalization and up to 30 days postoperatively if available through routine clinical follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Stephen J Warner, MD, PhD、The University of Texas Health Science Center, Houston
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年8月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年8月17日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HSC-MS-26-0228
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いいえ
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米国で製造され、米国から輸出された製品。
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