Upper Abdominal SurgeryVALUENCT07678502
Non-Invasive Respiratory Monitoring to Predict Successful Separation From Mechanical Ventilation Following Upper Abdominal Surgery
An observational study of Upper Abdominal Surgery and Critical Ill Patients in SICU, run by Papawee Chennavasin.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Abdominal Surgery, Critical Ill Patients in SICU
- What is being tested?
- High Flow Oxygen and Nasal canula oxygen
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post upper abdominal surgery patient with endotracheal tube
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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]).
Read the detailed description
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.
- Being tested
- High Flow Oxygen, Nasal canula oxygen
- Keywords
- pulmonary complication, postoperative care, upper abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow OxygenDevice
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 oxygenDevice
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (3)
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.
Measured: 7 days
Duration of MV
Duration of MV after extubation
Measured: 30 days
ICU length of stay
Total days from immediate postoperative ICU admission to discharge from ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papawee Chennavasin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Papawee Chennavasin, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678502
- Sponsor's protocol ID
- IRB No. 0855/68
- Acronym
- VALUE
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07678502
- Acronym / sponsor ID
- VALUE / IRB No. 0855/68
- Keywords
- pulmonary complication, postoperative care, upper abdominal surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Papawee ChennavasinUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post upper abdominal surgery patient with endotracheal tube
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Previous tracheostomy
- Contraindication to EIT placement: pacemaker/defibrillator implantation, burns at the area of EIT placement
- Patient with end-of-life plan
- Emergency operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow OxygenIf 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 oxygenif 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) | Device | – |
Primary outcome
The prevalence of success vs failure after extubation
Time frame: 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
3 secondary outcomes
Post extubation pulmonary complications
Time frame: 7 days
Duration of MV
Time frame: 30 days
ICU length of stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Abdominal Surgery and Critical Ill Patients in SICU, run by Papawee Chennavasin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Papawee Chennavasin, MD (+667843160, papawee.c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of success vs failure after extubation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.