NCT07199881 Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery
| NCT ID | NCT07199881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Inspiratory Effort |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-10-31 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This physiological observational study will assess respiratory drive and inspiratory effort across varying levels of pressure support ventilation (PSV) in adult surgical ICU (SICU) patients after major abdominal surgery. By using non-invasive bedside indices (airway occlusion pressure at 100 ms after the onset of inspiration \[P0.1\], maximum negative occlusion pressure \[Pocc\], and pressure muscle index \[PMI\]), we aim to quantify how patients adapt to changes in ventilatory support and determine patterns of under- and over-assistance. Findings may inform optimal titration of PSV to reduce complications and improve clinical outcomes.
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years) admitted to the surgical ICU * Recent major abdominal surgery (intra-peritoneal operation without primary thoracic involvement, including luminal resection and/or resection of a gastrointestinal solid organ) requiring postoperative ICU care * Receiving invasive mechanical ventilation in pressure support ventilation (PSV) mode at the time of enrollment * Duration of invasive mechanical ventilation \>48 hours * Clinically stable, with no plan for extubation within 6 hours of study enrollment, defined by all of the following: Respiratory rate \<35 breaths/min, SpO₂ ≥90%, Heart rate \<140 bpm, No visible accessory muscle use, Hemodynamically stable without escalation of vasopressor support during the past hour, Able to tolerate short-term adjustments in PSV level as per protocol Exclusion Criteria: * Known neuromuscular disease affecting respiratory muscle function * Hemodynamic instability requiring escalation of vasopressor support * Severe hypoxemic respiratory failure requiring Positive End-Expiratory Pressure (PEEP) \>10 cmH₂O or FiO₂ \>60% * Deep sedation (Richmond Agitation-Sedation Scale \[RASS\] score \< -3) or ongoing neuromuscular blockade * History of chronic obstructive pulmonary disease (COPD) or other obstructive lung disease
Contact & Investigator
Nuanprae Kitisin
PRINCIPAL INVESTIGATOR
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Frequently Asked Questions
Who can join the NCT07199881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inspiratory Effort. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07199881 currently recruiting?
Yes, NCT07199881 is actively recruiting participants. Contact the research team at nuanprae.kit@mahidol.ac.th for enrollment information.
Where is the NCT07199881 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT07199881 clinical trial?
NCT07199881 is sponsored by Mahidol University. The principal investigator is Nuanprae Kitisin at Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University. The trial plans to enroll 40 participants.