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临床试验/NCT07059728
NCT07059728尚未招募不适用

Uso de Lentillas de Alto Flujo en Procedimientos de sustitución de válvula aórtica transcatéter. Impacto en Las Complicaciones Respiratorias y Biomarcado- Res y Resultados clínicos. TAVR-Highflow

Hospital Clinic of Barcelona3 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2027年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
452
试验地点
3
主要终点
Postoperative complications

研究概览

简要总结

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy.

Patients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications.

TAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them.

When sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent.

For all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk.

The provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L/min without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable.

On the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L/min through specially adapted nasal cannulae and reliably deliver oxygen concentrations between 21% and 100%. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures, increasing oxygen content and minimizing hypercapnia.

The study's hypothesis is HFNO will prevent hypoxemia and control hypercapnia during sedation for transcatheter aortic valve implantation (TAVI) better than conventional oxygen theraphy. Clinical and serological biomarkers of tissue injury will decrease with the use of HFNO. Clinical complications will decrease with the use of HFNO.

The study population would be all patients >18 years of age undergoing TAVI procedure and who agree to participate in the study in 8 centers in Barcelona.

详细描述

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy. These technological advances have enabled a minimally invasive anesthetic approach that avoids mechanical ventilation, central line insertion, and urinary catheterization in most patients undergoing TAVR.

However, patients selected for this procedure often have a profile associated with multiple comorbidities such as pulmonary disease, ischemic coronary artery disease, and atherosclerosis of the carotid and renal arteries, which predispose them to certain complications.

Acute kidney injury (4%-35%), ischemic stroke (1%-3%), acute heart failure (7%-24%), and hypoxemia with hypercapnia are the most common perioperative complications. The overall 30-day mortality rate is 2.2%.

Because they are considered high-risk (both due to the procedure and the type of patient undergoing this procedure) and due to their duration, TAVI procedures were initially performed under general anesthesia. With improved procedure times and improved anesthetic techniques, the trend is to attempt to perform these procedures under deep sedation. As in many settings, sedation for diagnostic and/or therapeutic procedures can be achieved with a variety of medications, the goal of which is sedation to enable procedural success. The development and advancement of procedures as an alternative to surgery and/or more invasive diagnostic and therapeutic procedures means that the use of less invasive techniques is becoming increasingly common. Depending on the procedure, sedation may be required. However, despite the less invasive nature of these tests, deep sedation is frequently required for these procedures.

Deep sedation techniques have developed alongside technological advances that enable the provision of complex diagnostic and therapeutic procedures, often performed in settings outside the operating room. These settings include procedure rooms, radiology departments, outpatient departments, emergency rooms, surgical facilities, interventional cardiology departments, and so on. Deep sedation is used to support and enable the performance of these procedures. Enthusiasm for providing sedation for these procedures in a non-OR setting was tempered by an increase in mortality in non-OR areas, even leading one author to describe this as the "Wild West" of surgical and anesthetic practice. This required both professionals and regulatory authorities have developed increased oversight to improve the quality of care for out-of-the-operative procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Transfemoral TAVR elective procedure
  • Age >18 years

排除标准

  • Patients under 18 years of age
  • Refusal to participate
  • Known allergy to propofol or remifentanil.
  • Non-femoral surgical access.
  • Presence of a basal skull fracture or pneumothorax
  • Procedure duration < 45 minutes
  • Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons
  • Need to convert to general anesthesia for non-respiratory complications within 45 minutes.

研究组 & 干预措施

HFNO group

Experimental

Patients recieving high flow nasal oxygenation

干预措施: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2) (Device)

Control group

Active Comparator

Patients recieving standard of care oxygen theraphy (5L/min via nasal cannulae)

干预措施: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min (Device)

结局指标

主要结局

Postoperative complications

时间窗: From enrollment to 30 days after intervention

Reduction in complications at 30 days post-procedure). Classic composite variable that includes: 30-day post-procedure mortality, need for hospital readmission due to acute heart failure, incidence of stroke, and incidence of acute kidney injury.

Win ratio

时间窗: From enrollment to 30 days after the intervention ends

Win ratio analysis for outcomes: 30-day post-procedure mortality, need for hospital readmission for acute heart failure, incidence of acute stroke, incidence of acute kidney injury, and quality of life (measured by the Kansas Questionnaire)

Postoperative complications

时间窗: From enrollment to 30 days after intervention

Reduction in complications at 30 days post-procedure). Classic composite variable that includes: 30-day post-procedure mortality, need for hospital readmission due to acute heart failure, incidence of stroke, and incidence of acute kidney injury.

Win ratio

时间窗: From enrollment to 30 days after the intervention ends

Win ratio analysis for outcomes: 30-day post-procedure mortality, need for hospital readmission for acute heart failure, incidence of acute stroke, incidence of acute kidney injury, and quality of life (measured by the Kansas Questionnaire)

次要结局

  • Number of Desaturation episodes(From enrollment until end of TAVR procedure)
  • Desaturation incidence(From enrollment until the end of TAVR procedure)
  • PaO2(At enrollment and at 45 minutes after enrollment)
  • PaCO2(At enrollment and at 45 minutes after enrollment.)
  • Neuronal Specific Enolase(At enrollment and at 8 hours after enrollment.)
  • Creatinine(At enrollment and at 8 hours after enrollment.)
  • Troponin(At enrollment and at 8 hours after enrollment.)
  • NT-proBNP(At enrollment and at 8 hours after enrollment.)
  • Number of patients presenting with respiratory depression(From enrollment until the end of TAVR procedure)
  • Vasopressors(From enrollment until the end of TAVR procedure.)
  • Propofol and remifentanil(From enrollment until the end of TAVR procedure)
  • Procedural duration(Procedure (Time from start of sedation to when sedation drugs are stopped))
  • Number of patients presenting with respiratory depression(From enrollment until the end of TAVR procedure)
  • Vasopressors(From enrollment until the end of TAVR procedure.)
  • Propofol and remifentanil(From enrollment until the end of TAVR procedure)
  • Procedural duration(Procedure (Time from start of sedation to when sedation drugs are stopped))
  • PaCO2(At enrollment and at 45 minutes after enrollment.)
  • Troponin(At enrollment and at 8 hours after enrollment.)
  • NT-proBNP(At enrollment and at 8 hours after enrollment.)
  • Number of Desaturation episodes(From enrollment until end of TAVR procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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