임상 레이더 AI | ||
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임상시험 NCT07176624은(는) ARDS (Moderate or Severe), 엎드린 자세, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
The PRE-VAIL Study 259
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임상시험 NCT07176624은(는) ARDS (Moderate or Severe), 엎드린 자세, Enteral Nutrition Feeding, Intensive Care Unit (ICU) Admission에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 9월 14일에 시작되어 259명의 참여자를 모집하고 있습니다. The First Hospital of Jilin University이(가) 진행하며, 2028년 2월 20일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 9일에 갱신되었습니다.
간단한 개요
During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated acute respiratory distress syndrome (ARDS).
The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have th...
더 보기상세한 설명
During the prone position, there may be an increase in intragastric pressure. The investigators focus on a scientific question: Whether reducing enteral nutrition before the prone position will benefit patients with severe mechanically ventilated ARDS.
The experimental group had the enteral nutrition dose reduced before the prone position, while the control group did not have the enteral nutrition dose reduced
공식 제목
The Effect of Reducing Enteral Nutrition Before Prone Positioning on Clinical Outcomes in Mechanically Ventilated ARDS Patients: A Multicenter Randomized Controlled Trial (The PRE-VAIL Study)
질환명
ARDS (Moderate or Severe)엎드린 자세Enteral Nutrition FeedingIntensive Care Unit (ICU) Admission기타 연구 식별자
- The PRE-VAIL Study
NCT 번호
실제 연구 시작일
2025-09-14
최신 업데이트 게시
2026-02-09
예상 연구 완료일
2028-02-20
계획된 등록 인원
259
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
ARDS
Mechanical ventilation
Prone position
Enteral nutrition
Gastric retention
Clinical outcome
Mechanical ventilation
Prone position
Enteral nutrition
Gastric retention
Clinical outcome
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Enteral nutrition reduction group Before the prone position, the gastric contents are aspirated with a syringe, and the dose of enteral nutrition reduction is determined based on the different amounts of gastric residue. If the residual volume in the stomach is less than 200ml, the enteral nutrition intake will be reduced by one third. Gastric residual volume 200-500ml: Reduce enteral nutrition by half. If the residual gastric volume is greater than ...더 보기 | Enteral nutrition is reduced before the prone position Before the prone position, the gastric contents are aspirated with a syringe, and the dose of enteral nutrition reduction is determined based on the different amounts of gastric residue. If the residual volume in the stomach is less than 200ml, the enteral nutrition intake will be reduced by one third. Gastric residual volume 200-500ml: Reduce enteral nutrition by half. If the residual gastric volume is greater than ...더 보기 |
비개입Conventional feeding group Do not reduce the feeding speed before the prone position and continue to feed at the original speed | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The incidence of gastric retention during prone position | The incidence of gastric retention (with a single gastric residual volume \> 200ml) during prone position. | Acute stage of critical illness (within 7 days of Intensive Care Unit (ICU)) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The frequency of gastric retention during the prone position | The number of times of gastric retention (with a single gastric residual volume \> 200ml) per unit time during prone position (times per day) | Acute stage of critical illness (within 7 days of ICU) |
The incidence of diarrhea during ICU stay | Having three or more loose or liquid stools per day, with a stool weight greater than 200-250g/d (or more than 250ml/d) | Acute stage of critical illness (within 7 days of ICU) |
EN interruption rate | High gastric residual volume (single dose \> 500ml) or serious gastrointestinal adverse events lead to the need to suspend EN administration | Acute stage of critical illness (within 7 days of ICU) |
The incidence of Ventilator-associated pneumonia (VAP) among the participants | Pulmonary infectious inflammation that occurs 48 hours after the end of ventilator treatment is a type of hospital-acquired pneumonia | During the length of stay in the ICU (from day 1 to a maximum of 28 days) |
Nutrition compliance rate | Whether the patient reached 80% of the nutritional (calories: 25kcal/kg/day and protein :1.3g/kcal) target on the 7th day of hospitalization in the ICU | The seventh day in the ICU |
Gastric antral cross-sectional area (ACSA) measured by ultrasound after the end of prone positioning | The ultrasound cross-sectional area of the antrum of the stomach after adjusting to the normal position at the end of the prone position | After each prone position during the ICU stay |
Length of stay in the ICU | The number of days spent in the ICU | During the length of stay in the ICU (from day 1 to a maximum of 180 days) |
ICU mortality | Whether there was death during the ICU stay | During the length of stay in the ICU (from day 1 to a maximum of 180 days) |
28-day mortality | Whether the patient died on the 28th day after being admitted to the ICU | Day 28 after being admitted to the ICU |
90-day mortality | Whether the patient died on the 90th and 180th days after being admitted to the ICU | The 90th day after being admitted to the ICU |
180-day mortality | Whether the patient died on the 180th day after being admitted to the ICU | Day 180 after being admitted to the ICU |
The incidence of gastric retention during ICU stay | The incidence of gastric retention within 7 days of ICU hospitalization (The single gastric residual volume is greater than 200ml) | Within 1 to 7 days of hospitalization in the ICU |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Age ≥18 years old
- Within 24 hours of admission to the ICU, one or more organ systems have failed (the Sequential Organ Failure Assessment (SOFA) score of any single organ system is ≥2)
- Meet the diagnostic criteria for moderate/severe ARDS (even after optimizing the ventilation Settings, the oxygenation index is still < 150mmHg and PEEP is still ≥5 cm H2O)
- It is expected to stay in the ICU for more than 48 hours
- There are contraindications for the prone position
- There are contraindications for EN, preventing the initiation of early EN (≤48 hours)
- Expected to die within 48 hours
- Pregnancy
The First Hospital of Jilin University연구 대표 연락처
연락처: Youquan Wang, M.D., +8615584299391, [email protected]
1 1개국에 임상시험 장소
Jilin
The First Hospital of Jilin University, Changchun, Jilin, 130021, China
youquan Wang, 연락처, 15584299391, [email protected]
모집중