Abstract
BACKGROUND: Ultra-early physiotherapy mobilization within ERAS pathways (≤ 24 h) is a modifiable intervention with potential impact on recovery in patients with severe obesity undergoing laparoscopic sleeve gastrectomy (LSG). Incentive spirometry (IS) may serve as an adjunct; device configuration can influence inspiratory mechanics and early ventilatory recovery. METHODS: This was a prospective, single-center randomized clinical trial conducted at a metabolic bariatric surgery center (October 2019–October 2022). Adults undergoing elective LSG were randomized to flow-oriented IS (Flow-IS; n = 88) or volume-oriented IS (Volume-IS; n = 75). All patients followed a standardized ERAS pathway with physiotherapy-led mobilization initiated within 60 min of extubation. Spirometry was assessed preoperatively (PRE), immediately postoperatively (POi), and on postoperative day 1 (PO1) according to ATS/ERS standards. The primary endpoint was the change in maximal voluntary ventilation (MVV, L/min) from POi to PO1, analyzed using ANCOVA adjusted for baseline MVV and pre-specified covariates. Secondary outcomes included FVC, FEV₁, PEF, oxygenation, hemodynamics, dyspnea, pain, and 90-day respiratory events. RESULTS: A total of 163 patients were randomized; >95% completed PO1 assessments. Volume-IS yielded significantly greater MVV recovery from POi to PO1 compared with Flow-IS (adjusted difference + 12.6 L/min; 95% CI 9.3–15.9; p < 0.001). Secondary trajectories favored Volume-IS for FVC, FEV₁, and PEF (all p < 0.01), with comparable hemodynamic profiles. No ICU admissions, respiratory complications, or readmissions occurred within 90 days. CONCLUSION: Within ERAS for LSG, ultra-early physiotherapy mobilization represents a key component of safe recovery. IS is adjunctive; volume-oriented devices provide modest, consistent improvements in early spirometric recovery compared with flow-oriented systems. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11695-026-08519-2.