Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)
2018年9月5日 更新者：Nestlé
Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.
調査の概要
詳細な説明
Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.
Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).
研究の種類
観察的
入学 (実際)
12
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。
研究場所
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Bern、スイス、3010
- Universitätsklinik für Intensivmedizin
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube
説明
Inclusion Criteria:
Healthy volunteers
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >18 years
Patients
- Age >18 years
- mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications
- Informed Consent as documented by signature of relatives
Exclusion Criteria:
Healthy volunteers and patients
- Unrepaired tracheoesophageal fistula
- history of prior esophageal or gastric surgery
- esophageal obstruction, stricture, varices or diverticulum
- esophageal or gastric perforation, gastric or esophageal bleeding
- recent oropharyngeal surgery
- cervical spine injury or anomaly
Additional exclusion criterion for patients only
• know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) > 3)
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
- 観測モデル：コホート
- 時間の展望：他の
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Volunteers
Cohort of 10 healthy subjects.
The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement.
Secondly, a second tube will be placed and removed.
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Placement of enteral feeding tubes
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Mechanically ventilated ICU
Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications.
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Placement of enteral feeding tubes
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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 |
|---|---|---|
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Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
時間枠：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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In healthy volunteers, time required to reach gastric and postpyloric placement
時間枠：During Intervention Visit, an average of 24 hours
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Questionnaire with various positions and the time to reach the position
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During Intervention Visit, an average of 24 hours
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In healthy volunteers, ease of insertion, handling, and image quality assessed
時間枠：During Intervention Visit, an average of 24 hours
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Using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
時間枠：During Intervention Visit, an average of 24 hours
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Using a visual analog scale of 1-10, with 1 indicating the best value.
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During Intervention Visit, an average of 24 hours
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In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
時間枠：During Intervention Visit, an average of 24 hours
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Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
時間枠：During Intervention Visit, an average of 24 hours
|
using a visual analog scale of 1-10, with 1 indicating the best value
|
During Intervention Visit, an average of 24 hours
|
|
In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
時間枠：During Intervention Visit, an average of 24 hours
|
using a visual analog scale of 1-10, with 1 indicating the best value
|
During Intervention Visit, an average of 24 hours
|
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In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
時間枠：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Time required to reach gastric and postpyloric placement
時間枠：During Intervention Visit, an average of 24 hours
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Questionnaire
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During Intervention Visit, an average of 24 hours
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In patients: Feasibility of the feeding through Veritract tube.
時間枠：During Intervention Visit, an average of 24 hours
|
using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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Bleeding and infection related to tube placement
時間枠：During Intervention Visit, an average of 24 hours
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AE/SAE Questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Erroneous placement in larynx and trachea and associated complications (pneumothorax).
時間枠：During Intervention Visit, an average of 24 hours
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Outcome mesured with a questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Injuries of the oesophagus, stomach or small intestine related to tube placement.
時間枠：During Intervention Visit, an average of 24 hours
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Outcome mesured with a questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Reflux of stomach contents during tube placement
時間枠：During Intervention Visit, an average of 24 hours
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AE/SAE Questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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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。
スポンサー
捜査官
- 主任研究者：Tobias Merz, Dr. med.、Inselspital Bern, Universitätsklinik für Intensivmedizin
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 (実際)
2017年11月6日
一次修了 (実際)
2018年6月7日
研究の完了 (実際)
2018年7月30日
試験登録日
最初に提出
2016年12月22日
QC基準を満たした最初の提出物
2018年4月26日
最初の投稿 (実際)
2018年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月7日
QC基準を満たした最後の更新が送信されました
2018年9月5日
最終確認日
2018年9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
- 16.22.CLI
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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