Prevention of Desaturations Using Positive Airway Pressure or Capnometry During ERCP

Официальное название

A Randomized, Controlled, Unblinded Trial Evaluating the Impact of Positive Airway Pressure and Capnometry Compared to Standard Management on the Rate of Desaturations During Nurse-administered Sedation ERCP

Обзор

Although sedation during endoscopy is sufficiently safe, desaturations are among the most common side effects of endoscopic retrograde cholangiopancreatography (ERCP) procedures, occurring in approximately 20-30% of cases. Sedation during endoscopy increases the complication rate, and a significant proportion of severe and serious side effects are respiratory/airway-related. However, most patients require sedation to complete the procedure and achieve adequate outcomes during therapeutic ERCP. Therefore, improved measures to increase ERCP safety are needed. Since the demand for anesthesia in many centers already (far) exceeds current capacities, performing additional ERCPs under general anesthesia is not an option. Innovative ways to improve cardiorespiratory monitoring or respiratory management during ERCP could offer a solution without significantly increasing costs. Fortunately, dedicated devices for respiratory management and/or monitoring during endoscopy already exist, but their impact on improving patient safety has not yet been well studied. Therefore, the aim of this prospective, randomized, open-label, non-interventional study is to investigate the effects of non-invasive airway management and respiratory monitoring devices on desaturation rate during endoscopic retrograde cholangiopancreatography. For this purpose, 288 adult patients (male and female, 18+ years) undergoing ERCP for medical reasons will be enrolled and randomized to one of three groups: (i) airway management using positive airway pressure (PAP group), (ii) additional monitoring using capnography (capnography group), and (iii) a control group with standard monitoring/treatment (i.e., 2 L O2/min via nasal cannula) (control group). Patients are monitored during the ERCP procedure according to medical standards (non-invasive blood oxygen saturation measurement = SpO2, regular non-invasive blood pressure measurement, pulse), and all desaturation events (defined as an SpO2 \<85% for any duration according to guidelines) are recorded and treated according to guideline recommendations (the studies do not specify any measures for the (non-)treatment of desaturations). After the procedure, patients are followed (passively) for 30 days (review of medical records) to record late complications. The main outcome parameter is the comparison of the desaturation rate in the PAP versus the control group.

Вмешательства

• Устройство Nasal PAP Ventilation System
  medical devices that provide nasal positive airway pressure ventilation during endoscopy
• Устройство Low Flow Oxygen
  low flow oxygen though nasal cannula
• Устройство Capnometry
  capnometry measurement

Первичные конечные точки

• Difference in desaturation rate [Срок оценки: during endoscopic retrograde cholangio-pancreatography]

Вторичные конечные точки (11)

• Difference in desaturation rate [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Difference in desaturation rate [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Difference in desaturation rate [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Rates of interventions for hypoxemic events [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Rates of interventions for hypoxemic events [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Rates of interventions for hypoxemic events [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Lowest SpO2 [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Median procedure length [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Satisfaction with sedation [Срок оценки: Periprocedural]
• Rate of sedation-related adverse events [Срок оценки: during endoscopic retrograde cholangio-pancreatography]
• Rate of SCOPE [Срок оценки: from ERCP up to 30 days after procedure]

Критерии участия

Критерии включения

• undergoing an interventional (intent) ERCP procedure
• 18-99 years
• Male or female
• Nurse-administered sedation

Критерии исключения

• History of allergic reaction to Propofol
• Tracheostomy
• Procedure requiring intubation, general anesthesia, or anesthesiologist backup (acute exacerbation of obstructive lung disease, acute congestive heart failure, supra-glottic or sub-glottic tumor, septic shock, e.g.) according to the endoscopist in charge
• Pregnant patients

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Австрия · 2 центра

• Division of Gastroenterology and Hepatology, Department of Medicine, Medical University Gr — Graz
• Department of Internal Medicine 2, University Hospital of St Pölten — Sankt Pölten

Идентификаторы

NCT: NCT07056075 · PrePAP-ERCP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗