Non-Invasive Respiratory Monitoring to Predict Successful Separation From Mechanical Ventilation Following Upper Abdominal Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPapawee Chennavasin

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • High Flow Oxygen

    Device

    If 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

    Device

    if 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
7 days

Secondary outcomes

1

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.

Time frame
7 days
2

Duration of MV

Duration of MV after extubation

Time frame
30 days
3

ICU length of stay

Total days from immediate postoperative ICU admission to discharge from ICU

Time frame
30 days

Other outcomes

Locations

This trial has no 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

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