- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07678502
Non-Invasive Respiratory Monitoring to Predict Successful Separation From Mechanical Ventilation Following Upper Abdominal Surgery (VALUE)
NON-INVASIVE RESPIRATORY MONITORING TO PREDICT A SEPARATION FROM MECHANICAL VENTILATION IN PATIENTS WITH UPPER ABDOMINAL SURGERY: THE VALUE STUDY - PREVALENCE, PREDICTIVE AND PRAGMATICAL STUDY
The VALUE Study is a two-phase, prospective clinical trial conducted at King Chulalongkorn Memorial Hospital (KCMH). The study evaluates the prevalence of mechanical ventilation (MV) separation failure in post-open upper abdominal surgery patients and investigates whether non-invasive bedside respiratory monitoring tools can rapidly predict extubation failure.
The protocol focuses on Electrical Impedance Tomography (EIT) metrics-specifically regional ventilation distribution and the absolute ventral-to-dorsal difference-alongside ventilator-derived measures of respiratory drive. It also tracks physiological responses and clinical outcomes, including dyspnea using the Intensive Care Respiratory Distress Observation Scale (IC-RDOS) and the ROX index, across standard post-extubation oxygen delivery methods (nasal cannula vs. High-Flow Nasal Cannula [HFNC]).
연구 개요
상세 설명
Postoperative patients undergoing upper abdominal surgery frequently require mechanical ventilation and are at increased risk of extubation failure because of impaired respiratory mechanics, postoperative pain, diaphragmatic dysfunction, and atelectasis. Failure of separation from mechanical ventilation is associated with prolonged intensive care unit (ICU) stay, increased healthcare utilization, and mortality. Although prophylactic high-flow nasal cannula (HFNC) is commonly used to reduce the risk of respiratory deterioration after extubation, clinicians currently lack reliable bedside tools that provide real-time physiological information to predict successful separation from mechanical ventilation and guide individualized respiratory support.
A preceding quality improvement audit conducted at King Chulalongkorn Memorial Hospital demonstrated a composite post-extubation failure rate of approximately 32% among postoperative upper abdominal surgery patients requiring mechanical ventilation. In addition, the investigators' precursor VISION study showed that an electrical impedance tomography (EIT)-derived absolute ventral-to-dorsal ventilation difference greater than 20% during a spontaneous breathing trial was associated with failure of liberation from mechanical ventilation. These findings provide the rationale for evaluating non-invasive physiological monitoring in this high-risk surgical population.
The VALUE study is a prospective, two-phase clinical investigation designed to determine the prevalence of separation failure from mechanical ventilation and to evaluate the predictive performance of non-invasive respiratory monitoring parameters. The study will enroll approximately 40 adult patients who require postoperative mechanical ventilation following upper abdominal surgery.
During the first phase, participants will undergo physiological assessment while receiving mechanical ventilation during spontaneous breathing. An EIT belt will be applied to continuously measure regional lung ventilation. Simultaneously, ventilator-derived indices of respiratory drive and inspiratory effort, including airway occlusion pressure (P0.1) and end-expiratory occlusion pressure-derived measurements (ΔPocc), will be recorded using standardized measurement procedures.
Following successful extubation, participants will enter the second phase, which consists of a prospective physiological crossover study. Oxygen therapy will be administered according to routine clinical practice, with the treating clinical team selecting the initial oxygen delivery device. Participants will then undergo an ABA crossover sequence between conventional nasal prong oxygen therapy and high-flow nasal cannula, with each intervention maintained for a standardized 10-minute period. This design allows comparison of physiological responses while minimizing potential carryover effects without requiring an unsafe room-air washout period.
Throughout both study phases, EIT will continuously measure regional ventilation distribution, while additional non-invasive physiological variables, including respiratory drive, inspiratory effort, respiratory rate, oxygenation indices, and clinical respiratory distress scores, will be collected using standardized protocols. Participants will be followed for seven days after extubation to evaluate clinical outcomes related to separation from mechanical ventilation and postoperative pulmonary complications.
The study is designed to determine whether bedside physiological monitoring using EIT and complementary non-invasive respiratory measurements can improve prediction of successful separation from mechanical ventilation and provide insights into the physiological effects of different post-extubation oxygen delivery strategies in patients undergoing upper abdominal surgery.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Papawee Chennavasin, MD
- 전화번호: +667843160
- 이메일: papawee.c@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion criteria
- Age of ≥ 18 years
- Post elective open upper abdominal surgery with mechanical ventilation
- Get readiness for mechanical ventilation weaning with pressure support 5-8 cmH2O and PEEP 5-8 cmH2O set by clinical team and prompt extubation assessed by clinical team
Exclusion criteria
- Previous tracheostomy
- Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement
- Patient with end-of-life plan
- Emergency operation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The prevalence of success vs failure after extubation
기간: 7 days
|
MV separation failure including i) reintubation within 7 days after extubation, ii) death within 7 days after extubation, iii) tracheostomy without trying extubation, or iv) step-up to use HFNC due to worsening respiratory symptoms (decided by clinical team) in patients using nasal prong within 7 days after extubation
|
7 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post extubation pulmonary complications
기간: 7 days
|
new pneumonia - clinical of pulmonary infection (fever, cough, purulent secretion, dyspnea, and/or desaturation) with new pulmonary infiltrations; new pulmonary edema - clinical of dyspnea, cough, orthopnea/PND, with congestive pulmonary edema radiographic patterns; new pleural effusion - seen from radiographic imaging which it has never presented pre-operation or immediate post operation (before extubation); new atelectasis by radiographic imaging which it has never presented pre-operation or immediate post operation (before extubution), occurs 7 days from post-extubaton.
|
7 days
|
|
Duration of MV
기간: 30 days
|
Duration of MV after extubation
|
30 days
|
|
ICU length of stay
기간: 30 days
|
Total days from immediate postoperative ICU admission to discharge from ICU
|
30 days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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