Video-guided Percutaneous Tracheostomy (PCT): A Feasibility Study
Video-guided Percutaneous Tracheostomy (PCT): Evaluating the Safety, Efficacy and Simplicity of a Novel Technique
調査の概要
詳細な説明
Background
Percutaneous tracheostomy (PCT) is commonly used in the intensive care unit (ICU) for critically-ill patients who require long-term mechanical ventilation. In experienced hands, and with proper patient selection, it is safe, easy and quick, and the associated perioperative complication rate can be reduced to approximately 4% [1-7]. However, skilled intensivist may not always be available, and the procedure may sometimes entail complications. These include paratracheal insertion of the tracheostomy tube, tracheal injury; puncturing the cuff and transfixing the endotracheal tube (ETT) during the transtracheal needle insertion; inserting the guide wire through Murphy's eye; or accidental extubation while withdrawing the endotracheal tube during the procedure leading to loss of the airway [8-13].
Although using the fingertip to palpate the trachea and endotracheal tube is a useful technique to locate the tip of the endotracheal tube during the procedure, it is unreliable, particularly in patients with short and thick necks. Bronchoscopic guidance of PCT is generally recommended to minimize the risk of unintentional tracheal injury. The use of a fibreoptic bronchoscope may be helpful [14-18]. However, it is an expensive tool which is not readily available in some centers. Video guidance provides a cost-effective alternative to bronchoscopes, that may also reduce the risk of procedure-related complications such as paratracheal insertion of the tracheostomy tube, tracheal injury or cuff puncture [19].
The goal of this study is to observe and describe a simple and safe technique - Video-guided PCT - that may overcome some of the limitations of percutaneous tracheostomy, to report any potentially-related complications that may occur during or after the procedure, and to portray a learning curve obtained with this technique.
The equipment used for this technique is the ETView TVTTM, a commercially available ETT, embedded with a mini video-camera at the tip of the tube. It provides direct endoscopic visualization of the larynx and tracheal mucosa, and thereafter allows the determination of the tip of the transtracheal needle during percutaneous puncture of the trachea, and hence may reduce the likelihood of paratracheal insertion, tracheal injury, or other technical complications.
The ETView TVTTM device is compatible with any medical grade NTSC video monitor, thereby it provides monitoring of the airways during the intubation and PCT procedure, as well as continuous viewing of the airways as long as mechanical ventilation is required (www.etview.com).
Study Objectives
To observe a new bedside technique of video-guided PCT, to report any potentially-related complications, and to construct learning curves based on the operative time and complication rate.
Study design
The study will be conducted as a prospective observational one. The setting will be the ICU of the Sourasky medical center. 10 consecutive adult critically ill patients who require elective tracheostomy will be recruited for the study. Informed consent will be obtained from the families or next of kin of all study patients. In the absence of relatives, consent will be given by an anesthesiologist/intensivist not related to the study. The procedure will be performed by the same team of intensivists upon all study patients. During and following the procedure we will assess the complication rate, operative time, and operability of the procedure (see "procedure & follow-up" section).
Methods
The procedure
The procedure will be performed by an ICU team which includes: an anesthesiologist/intensivist who executes the procedure, another anesthesiologist who applies anesthetics & analgesia, a nurse, and a forth person who takes time.
During the procedures oxygen saturation, end tidal carbon dioxide (ETCO2), ECG, blood pressure, and arterial blood gases will be monitored continuously.
The video-guided PCT procedure requires extubation and re-intubation with the TVTTM tube, which will be mentioned in the consent form.
Re-intubation with the TVTTM tube will be performed as any commonly practiced intubation.
The ETView Tracheoscopic system (TVTTM) consists of an ETT, embedded with a video imaging device and a light source at its tip and an integrated cable with a connector, that may be wired to any video monitor.
The imaging system will be used to monitor the airways while intubating and, beyond the vocal cords, to locate the transtracheal insertion site and needle. In addition, the light source will serve for transillumination of the neck soft tissues, in order to delineate the tracheal curvature and identify anatomical deviations.
Anesthesia and analgesia will be routinely performed, and standardized for all the study patients. Low doses of the opiate fentanyl (2-3 μg/kg) and the short-acting sedative propofol (20 mg bolus, and 3-6mg/kg/h drip) will be administered at the beginning of the procedure. Rocuronium bromide, a brief acting muscle paralyzer, 0.6mg/kg, will also be used in most patients.
Patient follow-up
The executing physician will answer a questionnaire evaluating the intraprocedural difficulties, complications, feasibility, confidence, and operability, and will follow-up the patients during the first 6h after the procedure, or until discharge. Follow-up will include documentation of any procedure-related complications, monitoring of respiratory/ventilatory parameters and length of stay (LOS) in the ICU beyond 6h (due to medical circumstances related to the procedure).
All study patients will be placed with arterial lines through which we withdraw blood before and after the procedure, and when indicated by deterioration of respiratory parameters - for blood gas analyses (PaO2/FiO2, PaCO2, pH and BE). In addition, saturation will be documented hourly. All patients will also have chest x-rays performed immediately following tracheostomy.
The questionnaire will include a check-list listing procedure-related complications, through which we will evaluate the total number of complications. These include:
A. Technical complications: False route/paratracheal insertion, injury to a thoracic vessel, tracheal/laryngeal/esophageal injury, accidental decannulation, puncturing the cuff, inserting the guide wire through Murphy's eye, malpositioning or kinking of the tracheal cannula, failed trachestomy, multiple punctures (≥3).
B. Clinical complications potentially related to the procedure:
B.1. Intraprocedural: significant endotracheal bleeding and transfusion requirements (RBC, FFP or platelets), transient hypoxia/hypoxemia, hemodynamic changes (e.g., transient hypotension not related to anesthetics).
B.2. Postprocedure: alterations in respiratory function (defined as >15% reduction in saturation or PaO2/FiO2, compared to baseline; Increased PaCO2 without change in saturation; the need to change ventilatory settings and/or add PEEP within the first 24 hrs), atelectasis, pneumothorax, pneumomediastinum, aspiration, early unexplained mortality (within the first 24 hrs).
Other parameters they will be asked to evaluate will be: whether the transtracheal needle was recognized via the TVTTM (yes/no); intraoperative difficulties; level of confidence; ease of performance ("best practice"); and need to convert to surgical tracheostomy procedure.
In addition, a member of the team will measure operative time, which includes the total duration of the procedure; the time it took to recognize the tracheal insertion site and needle; and the time since ETT placement and until successful tracheal placement is confirmed via air bubbles or ETCO2.
The complication rate and operative time will be used to construct a learning curve for the executing intensivist.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Patrick Sorkine, MD
- 電話番号:97236973390
- メール:patricks@tasmc.health.gov.il
研究場所
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Tel-Aviv、イスラエル、64239
- Tel-Aviv Sourasky Medical Center
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コンタクト:
- Patrick Sorkine, MD
- 電話番号:97236973390
- メール:patricks@tasmc.health.gov.il
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副調査官:
- Esther Dahan, MD
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副調査官:
- Alex Segerman, MD
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主任研究者:
- Dima Shmain, MD
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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
説明
Inclusion Criteria:
- The investigators will enroll for this study
- patients aged > 18 years old, admitted to the ICU,
- who require elective PCT for prolonged mechanical ventilation, airway protection or weaning failure.
Exclusion Criteria:
- Patients indicated for surgical tracheostomy, due to altered or difficult local anatomy;
- necessity of emergency airway access due to acute airway compromise;
- evidence of infection in the soft tissues of the neck;
- coagulation abnormalities (INR>1.5, PTT>40, thrombocyte count < 50,000);
- gross distortion of the neck anatomy (due to hematoma/tumor/thyromegaly/scarring from previous neck surgery/ unstable C-spine);
- contra-indication for re-intubation/suspected loss of airway during re-intubation;
- hemodynamic instability.
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:支持療法
- 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:独身
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:Video-guided PCT
Patients that will be extubated and re-intubated with the ETT-TVT, and monitored throughout intubation and PCT
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extubation and then re-intubation with the ETT-TVT, followed by video monitoring of the PCT procedure via the ETT-TVT
他の名前:
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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 |
時間枠 |
---|---|
手術関連の合併症
時間枠:6時間
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6時間
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二次結果の測定
結果測定 |
時間枠 |
---|---|
手術時間
時間枠:分
|
分
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協力者と研究者
捜査官
- スタディディレクター:Patrick Sorkine, MD、Tel-Aviv Sourasky Medical Center
- 主任研究者:Dima Shmain, MD、Tel-Aviv Sourasky Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
video-guided PCTの臨床試験
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Zuyderland Medisch Centrum積極的、募集していない上肢骨折 | 橈骨遠位端骨折 | 上腕骨の近位端の骨折 | 上肢骨折オランダ
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Orthofix s.r.l.完了関節疾患 | ゲン・ヴァルム | Genu Valgum | 膝の変形 | 足首の変形 | 長さの不平等、脚 | 不一致の長さ;先天性 | 四肢の変形イタリア
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Tel-Aviv Sourasky Medical Centerわからない
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development募集
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University of Missouri-Columbia完了
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University of Roma La Sapienzaわからない