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

NCT07678502 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-07-01

No results posted yet for this study

Summary

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 \[HFNC\]).

Conditions

  • Upper Abdominal Surgery
  • Critical Ill Patients in SICU

Interventions

DEVICE

High Flow Oxygen

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.

DEVICE

Nasal canula oxygen

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)

Sponsors & Collaborators

  • Papawee Chennavasin

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-04-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678502 on ClinicalTrials.gov