Status:
RECRUITING
Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
Siriraj Hospital
Conditions:
Inspiratory Effort
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
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 majo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07199881
Start Date
October 31 2025
End Date
September 30 2027
Last Update
November 18 2025
Active Locations (1)
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1
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, Thailand, 10700