CHOP Clinical Trial Shows Early Tracheostomy Tube Change is Safe and Leads to Fewer Complications

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The insertion of a tracheostomy tube into a patient’s airway to assist with breathing is a complex procedure, with a complication rate of 20% to 51% in pediatric patients. Given the difficulties associated with the procedure, particularly in patients younger than 2 years old, timing of the first tracheostomy tube change is critically important. Historically, most surgeons have performed the tube change between five and seven days after placement, but the optimal timing of this procedure has not been established.

In a randomized controlled trial, researchers at Children’s Hospital of Philadelphia (CHOP) have shown that the first tracheostomy tube change in children can occur without adverse events four days after placement, resulting in fewer significant skin wounds around the opening and earlier discharge from intensive care. The findings were recently published in Otolaryngology—Head and Neck Surgery.

“Confidence that clinicians can perform the first tracheostomy tube change safely remains paramount to both clinicians and patients,” said study co-author Rosemary Patel, MSN, CRNP, a nurse practitioner in the Division of Otolaryngology and the Center for Pediatric Airway Disorders, a CHOP Frontier Program. “The results from this small trial highlight the benefits of an earlier first change, with no adverse events of a first tube change at four days and fewer complications when compared to a first tube change at seven days.”

The researchers enrolled 16 patients aged 24 months or younger into the trial (median age 5.9 months), with 10 patients randomized to an early change at four days and the other six patients randomized to a change at seven days. Significant wounds developed in only 10% of children with early tracheostomy tube changes, whereas such wounds developed in 83% of children with late tracheostomy tube changes. Given the significant improvement in wound development among the early change group, the researchers concluded trial enrollment earlier than anticipated. The early change group also had more positive outcomes when it came to discharge from intensive care: 90% were discharged from intensive care within five weeks, compared to 33% of patients in the late group.

“These results provide guidance for institutions if they would like to consider earlier tracheostomy tube changes for the benefits of improvement of wound healing and faster ICU transfer,” Patel said. “In addition to the medical benefits, early tracheostomy tube change may potentially result in earlier hospital discharge and, by inference, lower cost of hospital care.”

Contact: Natalie Solimeo, The Children’s Hospital of Philadelphia, 267-426-6246 or