Trials · 2026
Impact of early tracheostomy in infratentorial lesions trial: rationale and design.
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Han Song, Li Meng-Ya, Cheng Yuan-Chao, Yan Chang-Xiang
Аннотация
BACKGROUND: Tracheostomy is a common procedure in patients who undergo surgical resection of infratentorial lesions. However, the optimal timing and high-risk factors for tracheostomy remain unknown.
METHODS: Value of Early versus Standard Tracheostomy in patients with Infratentorial Lesions (VENTIL) is a prospective, randomized, controlled, open-blinded endpoint (PROBE design) trial. Patients who have undergone resection of infratentorial lesions will be recruited within 48 h postoperatively based on a prediction score. This study will include 152 patients. Patients will be randomized 1:1 to either the early tracheostomy (< 2 days after surgery) or the control group (≥ 2 days after surgery). The primary endpoint is the occurrence of pneumonia by day 14 after resection of infratentorial lesions. The secondary endpoints include the modified Rankin scale score at 6 months, mortality, length of intensive care unit and hospital stays, time to successful extubation, and adverse events.
CONCLUSION: High-risk factors and optimal timing for tracheostomy in patients undergoing resection of infratentorial lesions need to be identified. Therefore, VENTIL should clarify the clinical benefits of early tracheostomy in these patients.
TRIAL REGISTRATION: This trial is registered on February 5, 2024, at chictr.org.cn (ChiCTR2400080714).
METHODS: Value of Early versus Standard Tracheostomy in patients with Infratentorial Lesions (VENTIL) is a prospective, randomized, controlled, open-blinded endpoint (PROBE design) trial. Patients who have undergone resection of infratentorial lesions will be recruited within 48 h postoperatively based on a prediction score. This study will include 152 patients. Patients will be randomized 1:1 to either the early tracheostomy (< 2 days after surgery) or the control group (≥ 2 days after surgery). The primary endpoint is the occurrence of pneumonia by day 14 after resection of infratentorial lesions. The secondary endpoints include the modified Rankin scale score at 6 months, mortality, length of intensive care unit and hospital stays, time to successful extubation, and adverse events.
CONCLUSION: High-risk factors and optimal timing for tracheostomy in patients undergoing resection of infratentorial lesions need to be identified. Therefore, VENTIL should clarify the clinical benefits of early tracheostomy in these patients.
TRIAL REGISTRATION: This trial is registered on February 5, 2024, at chictr.org.cn (ChiCTR2400080714).