Randomized clinical trial of ventilator liberation with pressure support ventilation versus therapist-implement patient-specific weaning in prolonged weaning patients via tracheostomy.

Background: Liberation from prolonged mechanical ventilation is challenging and its outcomes are poor. Patients who failed at least three spontaneous breathing trials, often referred to as prolonged weaning patients, are usually weaned with protocolized programs in specialized weaning units, but there are no standardized strategies to facilitate their ventilator liberation. The objective of this study was to compare the ventilator liberation rate of two common ventilator weaning programs.

Methods: Tracheostomized patients with ongoing invasive mechanical ventilation for at least 21 day who were admitted to Barlow Respiratory Hospital for ventilator weaning were studied. Patients who passed spontaneous breathing trial on admission were excluded. In a prospective parallel group, non-blinded clinical study, patients were randomized to receive either the Pressure Support Ventilation (PSV) weaning program or the Therapist-Implemented Patient-Specific (TIPS) weaning program. Randomization was performed using a computer algorithm of block design. The primary outcome was ventilator liberation success. The secondary outcomes were hospital length of stay, physical recovery, discharge disposition and mortality. Significant hospital events were also compared between the groups.

Results: N = 25 patients were studied in PSV and N = 26 in the TIPS group. Outcomes were reported for all patients. The liberation success rate at 30 days was 37.5% (standard error, SE = 9.9%) in the PSV and 46.2% (SE = 9.8%) in the TIPS group (p = 0.58, odds ratio, OR 1.42, RD 8.7%, 95% confidence interval, CI=-18.6-35.9). The liberation rate at discharge was 44% (SE = 9.9%) in the PSV group and 53.8% (SE = 9.8%) in the TIPS group (p = 0.54, OR:1.48, RD 9.8%, CI=-17.2-37.2%). The inpatient mortality was: PSV = 24% (SE 8.5%) and TIPS = 11.5% (SE 6.3%), p = 0.291, OR 0.413, RD=-12.5%, CI=-33.2-8.3%. We did not find a significant difference between the two ventilator weaning programs in any of our outcomes, but our study describes a very sick patient population. Continued weaning beyond 30 days had improved liberation success.

Conclusions: Both weaning paths are equally beneficial for prolonged mechanical ventilation patients who undergo prolonged weaning.

Trial registration: The trial was registered retroactively at ClinicalTrials.gov, NCT06976554.