Assessment of Respiratory Drive and Inspiratory Effort Across Pressure Support Levels in Patients After Major Abdominal Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Stepwise PSV adjustment protocol

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single Cohort (Postoperative SICU patients on PSV >48h)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Respiratory drive and inspiratory effort across pressure support levels

Respiratory drive and inspiratory effort will be assessed using airway occlusion pressure at 0.1 seconds (P0.1), maximum negative inspiratory occlusion pressure (Pocc), and the pressure muscle index (PMI). These indices are measured non-invasively via ventilator maneuvers during standardized stepwise adjustments of pressure support ventilation (baseline, ±3 cmH₂O, ±6 cmH₂O, return to baseline). The mean of three repeated measurements at each step will be analyzed.

Time frame
Baseline and during protocol sessions, up to 3 days after enrollment

Secondary outcomes

1

Incidence of ventilatory response patterns during PSV

Ventilatory response patterns will be categorized as quasi-passive or active based on physiological criteria derived from changes in tidal volume, plateau pressure, and PMI during stepwise PSV adjustments. Patterns will be determined from individual response trends.

Time frame
Baseline and during protocol sessions, up to 3 days after enrollment
2

Duration of mechanical ventilation after protocol

Time from completion of the PSV protocol until successful extubation, measured in hours. Reintubation within 48 hours will be recorded separately.

Time frame
Within 48 hours after extubation
3

Reintubation or non-invasive ventilation use

Proportion of patients requiring reintubation or initiation of non-invasive ventilation within 48 hours after extubation following study participation.

Time frame
48 hours after extubation
4

ICU length of stay

Total number of days from ICU admission to ICU discharge.

Time frame
Through ICU stay, an average of 7-21 days

Other outcomes

Sponsors and contacts

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Mahidol University

Lead sponsor

Siriraj Hospital

Collaborator