About this trial
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 \[HFNC\]).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous tracheostomy
Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement
Patient with end-of-life plan
Emergency operation
Trial population
Post upper abdominal surgery patient with endotracheal tube
Trial design
Cohort
Prospective
Treatments tested in this trial
High Flow Oxygen
DeviceIf HFNC is used as the first device, the settings will be determined at the discretion of the clinical team. -If HFNC is used as the second device, the oxygen concentration (FiO₂) will be set equivalent to that of the nasal prong (using estimated FiO2 = current FiO2 + 0.03 \*O2 flow rate (L/min))(27), with a flow rate of 50 L/min. This is based on a 6-month SICU observation showing that nearly all patients after ventilator weaning were initially set on HFNC at 50 L/min and subsequently weaned down with FiO2 30-40%. This approach allows the HFNC settings to be as consistent as possible with routine attending physician practice and ensures that patients in this study receive HFNC settings that are as uniform as possible, without interfering with the primary treatment plan.
Nasal canula oxygen
Deviceif nasal prong is used as the first device, the setting will be determined at the discretion of the clinical team. If nasal prong is used as the second device, the FiO₂ will be set with a flow rate of 5 LPM (will be equivalent 40% of FiO2)
Treatment groups
Trial outcomes
Primary outcomes
The prevalence of success vs failure after extubation
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
Secondary outcomes
Post extubation pulmonary complications
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.
Duration of MV
Duration of MV after extubation
ICU length of stay
Total days from immediate postoperative ICU admission to discharge from ICU
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Papawee Chennavasin
Lead sponsor
King Chulalongkorn Memorial Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: