- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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]).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Papawee Chennavasin, MD
- Puhelinnumero: +667843160
- Sähköposti: papawee.c@gmail.com
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The prevalence of success vs failure after extubation
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Post extubation pulmonary complications
Aikaikkuna: 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
Aikaikkuna: 30 days
|
Duration of MV after extubation
|
30 days
|
|
ICU length of stay
Aikaikkuna: 30 days
|
Total days from immediate postoperative ICU admission to discharge from ICU
|
30 days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
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- IRB No. 0855/68
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