رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT06659159 (GLP-1) لـ Pulmonary Aspiration During Anaesthetic Induction هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying (GLP-1) ٥٠ غير جراحي رصدية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT06659159 (GLP-1) هي دراسة رصدية لـPulmonary Aspiration During Anaesthetic Induction وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ٢٩ ربيع الآخر ١٤٤٦ هـ لتجنيد ٥٠ مشاركًا. يقودها Sascha Battig، ومن المتوقع اكتمالها بحلول ٢٢ رجب ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٣ ربيع الآخر ١٤٤٦ هـ.
الملخص
This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surge...عرض المزيد
وصف مفصل
This project investigates the risk of pulmonary aspiration during anesthesia in patients undergoing treatment with GLP-1 agonists, a class of medications that prolong gastric emptying and are commonly used for obesity and diabetes management. Pulmonary aspiration remains a significant cause of morbidity and mortality in anesthesia-related complications, and patients with delayed gastric emptying are at higher risk. R...عرض المزيد
العنوان الرسمي
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying: a Prospective Ultrasound Approach with Focus on Perioperative Aspiration Risk.
الحالات الطبية
Pulmonary Aspiration During Anaesthetic Inductionمعرّفات دراسة أخرى
- GLP-1
- Effects of beginning a GLP1
- Hirslanden Klinik (رقم منحة/تمويل آخر) (Hirslanden Klinik, Zurich)
NCT معرّف
تاريخ البدء (فعلي)
2024-11-01
آخر تحديث مُنشور
2024-10-26
تاريخ الاكتمال (المقدر)
2026-12-31
عدد المشاركين المخطط لهم
٥٠
نوع الدراسة
رصدية
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Pulmonary aspiration
Gastric ultrasound
GLP-1
Gastroparesis
Gastric ultrasound
GLP-1
Gastroparesis
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
GLP-1, New Therapy Indication, prescription and dosage is determined independently of the study by the endocrinologist/obesity specialist, who is also part of the study team. Since the first gastric ultrasound will take place directly before the initiation of the GLP-1 Agonist therapy, the patients will serve as their own control group/baseline. | الموجات فوق الصوتية للمعدة The sequence in which the study is conducted will be as follows, the first examination (baseline examination) will take place immediately before the appointment and prescription of GLP-1 Analoga (before the first injection). During the examination the gastric content (quality/quantity) will be determined, secondly, a baseline for gastric emptying time after oral intake of 500ml of water is collected (patient drinks w...عرض المزيد |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Gastric content | Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Gastric emptying time | Sonographic measurement of gastric emptying time for 500ml of water before and during GLP-1 therapy. Gastric emptying time is measured with a continuous ultrasound examination. The variable of interest is once again the CSA of the gastric antrum and the time until the baseline from before water consumption is reached once again. | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Number of empty stomachs | Absolute number of empty stomachs after adhering to standardised perioperative fasting intervals (6 hours for solids and 2 hours for liquids) before and once (if therapy is continued: twice) during GLP-1 Agonist therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
BMI | Demographic data of the patient: BMI | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Gallbladder stones | Presence of gallbladder stones (cholecystolithiasis) | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-morbidities | Demographic data of the patients: Comorbidities | At the baseline examination at the first endocrinologic appointment |
Side effects GLP-1 | Collection of all side-effects of the GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Discontinuation GLP-1 | Number and reason for discontiuation of GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-medication | For gastric emptying relevant co-medications | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- Signed informed consent
- Known pregnancy, known lactation
- Underage (< 18 years)
- Absence of informed consent (missing or inability to provide)
- Anomalies of the gastrointestinal tract
- Known illnesses of the gastrointestinal tract
- Previous surgery of the gastrointestinal tract
- Elevated risk for hypoglycaemia (Sulfonylurea or Insulin)
- No investigator with completed structural education in gastric sonography is available
- Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination
Sascha Battigالجهة المسؤولة عن الدراسة
Sascha Battig, الراعي-المحقق, Prof. Dr. med. Michael Ganter, Klinik Hirslanden, Zurich
جهة اتصال مركزية للدراسة
جهة اتصال: Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med., +41 44 387 38 80, [email protected]
لا توجد بيانات موقع.