Nurse-Led 12-Element Tracheostomy Care Bundle Improves Outcomes in ICU Patients

For the roughly 10 to 15 percent of mechanically ventilated intensive care patients who require a tracheostomy, the procedure is only the beginning of a long and precarious journey. The surgical airway that sustains breathing can also become the gateway to infection, obstruction, and accidental decannulation, and the difference between recovery and deterioration often hinges on the consistency of bedside nursing care. A new quasi-experimental study conducted at Mansoura University Hospital in Egypt suggests that when that care is standardized into a structured, nurse-led bundle, patients fare measurably better on several critical fronts, from the integrity of the stoma site to the trajectory of physiological stability.

The research, published in Nursing Open, evaluated a 12-element tracheostomy care bundle adapted from an evidence-based guideline and delivered entirely by trained critical care nurses. The bundle operationalizes tracheostomy management through continuous physiological surveillance, scheduled suctioning, humidification, cuff pressure monitoring, structured stoma assessment, oral care, tube security checks, emergency equipment readiness, resuscitation preparedness, mobilization, and standardized documentation with defined escalation criteria. Crucially, each element was designed to target a specific mechanism of harm rather than to function as a generic checklist. Inadequate suctioning permits secretion accumulation and airway obstruction; unmonitored cuff pressure predisposes patients to mucosal injury and leak-related aspiration; inconsistent stoma assessment delays detection of local infection; and insufficient humidification promotes mucus plugging. Because each of these failure points is nursing-sensitive, the researchers argued that a structured, nurse-led response was needed to interrupt the complication pathway.

The study recruited 80 critically ill adult patients with tracheostomies, divided equally between a control cohort receiving routine care and an intervention cohort receiving the bundle. Allocation followed a sequential temporal design: all consecutive eligible patients admitted between January and April 2025 received routine care, while those admitted between June and September 2025, after a four-week nurse training program, received the bundle. This pragmatic approach prevented contamination between groups during staff education but, as the authors acknowledge, meant that participants were not randomly assigned, leaving open the possibility of selection bias. Six participants were lost during follow-up and replaced to maintain the planned sample size, and no adverse events directly attributable to the bundle were observed.

Outcomes were tracked with a battery of validated instruments applied at baseline, one week, and two weeks after tracheostomy insertion, or until discharge. The National Early Warning Score (NEWS) integrated seven physiological parameters, including respiratory rate, oxygen saturation, temperature, blood pressure, heart rate, and consciousness level, to detect clinical deterioration. The Respiratory Distress Observation Scale (RDOS) captured eight observable indicators of breathing difficulty, from accessory muscle use to facial expressions of fear, in patients too sedated or ventilated to report dyspnea themselves. A modified Clinical Pulmonary Infection Score (CPIS), excluding microbiological culture because results were not consistently available within 24 to 48 hours, screened for suspected respiratory infection. Inter-rater reliability testing during a pilot phase showed good agreement between independent assessors, with intraclass correlation coefficients of 0.82 for NEWS, 0.88 for RDOS, and 0.87 for the modified CPIS.

The results on stoma integrity were striking. At baseline, immediately after insertion, no patient in either group showed local abnormalities. By one week, however, the control group had begun to accumulate complications: 27.5 percent showed purulent discharge and 32.5 percent foul-smelling drainage, compared with 10.0 percent and 7.5 percent respectively in the bundle group. By two weeks, the gap widened further, with significant differences in redness, warmth around the stoma, and foul-smelling drainage. The overall stoma-integrity composite score averaged 0.80 in the intervention group at one week versus 1.85 in controls, and 0.43 versus 1.33 at two weeks. A longitudinal repeated-measures model confirmed a significant Group by Time interaction, meaning the two cohorts followed genuinely different trajectories rather than merely differing at a single snapshot.

Respiratory distress told a similar story. At baseline, roughly nine in ten patients in both groups showed no distress on the RDOS. At one week, 52.5 percent of bundle patients remained free of distress compared with just 10.0 percent of controls, and moderate or severe distress was concentrated in the routine-care group. At two weeks, 77.5 percent of intervention patients had no distress versus 47.5 percent of controls. The repeated-measures model again found a significant Group by Time interaction, indicating a steeper longitudinal reduction in distress among bundle recipients. The researchers attribute this to bundle components targeting airway patency, secretion management, and humidification, which allow earlier recognition and correction of airway problems before they escalate into overt respiratory compromise.

Physiological stability, measured through daily NEWS assessments over 15 days, also favored the intervention. Baseline risk categories were comparable between groups, but on days three and nine the bundle group had significantly fewer high-risk patients. Discharge patterns diverged even more dramatically: by day 11, 42.5 percent of intervention patients had achieved clinical stability and been discharged, compared with only 5.0 percent of controls, and by day 14 the figures were 60.0 percent versus 32.5 percent. The authors caution that discharge status was treated as a separate endpoint from NEWS classification, but the overall pattern points toward a faster transition to physiological stability under structured care.

One anticipated benefit did not materialize with statistical significance. Suspected early-onset respiratory infection at one week occurred in 20.0 percent of controls and 10.0 percent of bundle patients, and suspected late-onset infection at two weeks occurred in 10.0 percent versus 5.0 percent. The direction favored the intervention, but the differences did not reach significance, and the researchers are explicit that these findings should not be interpreted as evidence of a confirmed reduction in pneumonia. They point to the relatively small sample, the limited 15-day follow-up, and the absence of microbiological confirmation within the modified CPIS as constraints. Infection outcomes, they note, are shaped by baseline illness severity, ventilation duration, and colonization status, factors that nursing interventions alone may not fully modify and that may require longer observation and larger cohorts to detect meaningful change.

The study’s limitations deserve careful weight. Beyond the non-randomized design and the resulting risk of unmeasured confounding, blinding of bedside nurses was unfeasible for such a complex nursing intervention, leaving observational endpoints like stoma assessment and RDOS scoring susceptible to detection bias despite standardized criteria. Intervention fidelity was maintained through real-time supervision but was not quantified as a numerical adherence percentage, so the dose-response relationship across the 12 elements could not be measured. The single-center setting and localized ICU population also constrain generalizability, and the 15-day window precluded evaluation of decannulation success, late airway complications, or long-term infection dynamics.

Nevertheless, the findings carry practical weight for intensive care units everywhere. The clearest effects appeared on outcomes most directly tied to daily nursing practice, stoma-site management, respiratory monitoring, and early physiological assessment, suggesting that structured bundles work precisely where nurses work. The authors recommend incorporating the bundle into quality-improvement frameworks with standardized protocols, bedside checklists, documentation tools, and competency-based training, while calling for larger multicenter randomized trials with blinded assessors, microbiological confirmation, and quantitative fidelity tracking. Until such trials arrive, the study offers a compelling signal that empowering nurses with a systematic, evidence-based framework for tracheostomy care can translate into fewer wound complications, calmer breathing, and earlier stability for some of the most vulnerable patients in the hospital.

Subject of Research: Effect of a nurse-led tracheostomy care bundle on stoma integrity, respiratory distress, and pneumonia-related outcomes in critically ill ICU patients

Article Title: 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

Article References: Hammouda, E. Y., Zaky, M. E., Ahmed, M. S. A., Zahran, W. E.-K., & Mansour, H. E.-S. (2026). 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. Nursing Open, 13(10), Article e70861. https://doi.org/10.1002/nop2.70861

Image Credits: AI Generated

DOI: 10.1002/nop2.70861

Keywords: tracheostomy, nursing care bundle, intensive care, stoma integrity, respiratory distress, pneumonia, NEWS score, RDOS, CPIS, quasi-experimental study, patient safety, Egypt