Impact of a 12‐Element Nurse‐Led Tracheostomy Care Bundle on Stoma Integrity, Respiratory Distress and Suspected Pneumonia‐Related Outcomes Among Patients With Tracheostomies: A Quasi‐Experimental Study

AIM: To evaluate the impact of a 12-element nurse-led tracheostomy care bundle, compared with routine care, on stoma integrity, respiratory distress, and pneumonia-related outcomes among patients with tracheostomies. DESIGN: A quasi-experimental study was conducted among 80 critically ill patients with tracheostomies admitted to Mansoura University Hospital. Participants were allocated into a study group receiving a 12-element nurse-led tracheostomy care bundle and a control group receiving routine care (40 patients per group). Patients were followed for 15 days. Data were collected using stoma-site assessment, the National Early Warning Score (NEWS), the Respiratory Distress Observation Scale (RDOS), and the modified Clinical Pulmonary Infection Score (CPIS). Statistical analyses included chi-squared tests, Friedman tests for repeated measurements, and effect size estimation using partial eta squared. RESULTS: Baseline demographic and clinical characteristics were comparable between groups (p > 0.05). Primary longitudinal repeated-measures models revealed significant Group × Time interaction effects favouring the nurse-led bundle for physiological stability (NEWS: F = 7.838, p < 0.001, partial eta squared = 0.086), stoma integrity composite scores (F = 5.849, p < 0.001, partial eta squared = 0.048), and respiratory distress trajectories (RDOS: F = 4.382, p = 0.014, partial eta squared = 0.036). Secondary day-specific analyses showed lower stoma-site infection signs (swelling, purulent discharge, skin breakdown, redness, warmth, and foul drainage) in the intervention cohort during follow-up. Regarding pneumonia-related outcomes, CPIS-indicated suspected respiratory infection occurred less frequently in the study group (1-week: 10.0% vs. 20.0%; 2-week: 5.0% vs. 10.0%), though the difference was not statistically significant (Chi-square = 3.710, p = 0.168). CONCLUSIONS: A 12-element nurse-led tracheostomy care bundle was associated with improved stoma integrity, reduced observed respiratory distress, and favourable changes in physiological stability among patients with tracheostomies. Although lower proportions of CPIS-indicated suspected respiratory infection were observed in the bundle group, the difference was not statistically significant. Further multicentre controlled studies are required to determine the effect of standardized tracheostomy care bundles on pneumonia-related outcomes. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Standardizing tracheostomy management via a nurse-led bundle provides a structured, evidence-informed framework for ICU practice. For nurses, it ensures consistent airway management, stoma assessment, suctioning, humidification, cuff pressure monitoring, and documentation, enhancing procedural fidelity and patient safety. For patients, bundle adherence supports stoma integrity, reduces respiratory distress, and promotes physiological stability. These improvements may optimize ICU workflows, guide timely interventions, and support care transitions such as decannulation and discharge. Implementation should include staff training, standardized checklists, and monitoring to ensure fidelity and adaptability. While preliminary results are promising, further evaluation in diverse clinical settings is recommended before broad adoption. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.