Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery
NCT ID: NCT07199881
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-20
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single Cohort (Postoperative SICU patients on PSV >48h)
Adult patients admitted to the surgical ICU after major abdominal surgery who remain on pressure support ventilation (PSV) for more than 48 hours. Each participant will undergo a standardized stepwise protocol of PSV adjustment (baseline, -6 cmH₂O, -3 cmH₂O, +3 cmH₂O, +6 cmH₂O, return to baseline). At each step, a 2-minute stabilization is followed by repeated measurements of respiratory drive and inspiratory effort indices (P0.1, Pocc, PMI) and ventilatory parameters.
Stepwise PSV adjustment protocol
Patients will undergo standardized stepwise PSV changes (baseline, ±3 cmH₂O, ±6 cmH₂O, return to baseline), with 2-minute stabilization and repeated measurements of ventilatory parameters.
Interventions
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Stepwise PSV adjustment protocol
Patients will undergo standardized stepwise PSV changes (baseline, ±3 cmH₂O, ±6 cmH₂O, return to baseline), with 2-minute stabilization and repeated measurements of ventilatory parameters.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Siriraj Hospital
OTHER
Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Nuanprae Kitisin
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Locations
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Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkoknoi, Thailand
Countries
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Central Contacts
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Facility Contacts
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Nuanprae Kitisin, MD
Role: primary
References
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He Q, Lai Z, Peng S, Lin S, Mo G, Zhao X, Wang Z. Postoperative pulmonary complications after major abdominal surgery in elderly patients and its association with patient-controlled analgesia. BMC Geriatr. 2024 Sep 10;24(1):751. doi: 10.1186/s12877-024-05337-y.
Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
Courtney A, Clymo J, Dorudi Y, Moonesinghe SR, Dorudi S. Scoping review: The terminology used to describe major abdominal surgical procedures. World J Surg. 2024 Mar;48(3):574-584. doi: 10.1002/wjs.12084. Epub 2024 Feb 11.
Docci M, Foti G, Brochard L, Bellani G. Pressure support, patient effort and tidal volume: a conceptual model for a non linear interaction. Crit Care. 2024 Nov 6;28(1):358. doi: 10.1186/s13054-024-05144-2.
Al-Bassam W, Parikh T, Neto AS, Idrees Y, Kubicki MA, Hodgson CL, Subramaniam A, Reddy MP, Gullapalli N, Michel C, Matthewman MC, Naughton J, Pereira J, Shehabi Y, Bellomo R. Pressure support ventilation in intensive care patients receiving prolonged invasive ventilation. Crit Care Resusc. 2023 Oct 18;23(4):394-402. doi: 10.51893/2021.4.OA4. eCollection 2021 Dec 6.
van Oosten JP, Akoumianaki E, Jonkman AH. Monitoring respiratory muscles effort during mechanical ventilation. Curr Opin Crit Care. 2025 Feb 1;31(1):12-20. doi: 10.1097/MCC.0000000000001229. Epub 2024 Nov 14.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PSV-SICU_SIRIRAJ
Identifier Type: -
Identifier Source: org_study_id