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

NCT07678502 | Not Yet Recruiting DMC

• 1 other identifier: IRB No. 0855/68
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pulmonary complication; postoperative care; upper abdominal surgery

Outcome Measures

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

  7 days

Secondary Outcomes (3)

• Post extubation pulmonary complications

  7 days

• Duration of MV

  30 days

• ICU length of stay

  30 days

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Post upper abdominal surgery patient with endotracheal tube

You may qualify if:

• 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

You may not qualify if:

• Previous tracheostomy
• Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement
• Patient with end-of-life plan
• Emergency operation

Sponsors & Collaborators

• Papawee Chennavasin: lead

Central Study Contacts

Papawee Chennavasin, MD

CONTACT

+667843160; papawee.c@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share