Postoperative Complications Following Skull Base Tumor Resection

Recruiting

• Conditions: Skull Base Tumor; Postoperative Complications

• Registration Number: NCT06587906
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

The skull base tumor is located in the deep intracranial layer and is closely related to the brain stem and intracranial nerves. The incidence of postoperative complications after skull base tumor resection is high. Therefore, the perioperative management of skull base tumor resection is challenging.

Detailed Description

1. Postoperative pulmonary complications (PPCs), always had a 11.2%-24.6% high incidence rate. Pulmonary ultrasound (LUS), as a non-invasive diagnostic tool, has high accuracy in diagnosing pulmonary complications. Compared to traditional chest X-ray examinations, pulmonary ultrasound can identify PPCs such as atelectasis and pneumothorax earlier, and it is also more accurate in diagnosing lung consolidation.With relevant literature postoperative PACU pulmonary ultrasound is used to predict the area under the PPC curve (AUC) of 0.64 in patients within 8 days after non cardiac major surgery. Through pulmonary ultrasound examination, doctors can identify high-risk patients with pulmonary complications early after surgery. In this observational study, investigators aimed to assess the occurrence of PPCs within 7 days after surgery and evaluate the accuracy of preoperative and postoperative lung ultrasound scores in predicting PPCs.

2. Patients with skull base tumors often have a high risk of postoperative lower extremity venous thrombosis due to long operation time and many postoperative complications, such as long-term bed rest. If not treated in time, lower extremity venous thrombosis can cause disability, and severe cases can cause serious consequences such as pulmonary embolism due to thrombus detachment. In this observational study, investigators aimed to prospectively collect perioperative data and the occurrence of DVT.

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study Start: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Age 18 and above
• American Society of Anesthesiologists physical status I to III
• Undergoing elective resection of skull base tumors
• Obtaining written informed consent

Exclusion Criteria

• Heart failure, myocarditis, pericarditis, and cardiomyopathy
• Myocardial ischemia less than 6 months old
• Severe arrhythmia
• Severe bradycardia (heart rate below 50 beats per minute)
• Unable to complete preoperative cardiac assessment
• Severe liver dysfunction (Child Pugh C-grade)
• Severe lung diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative pulmonary complications	Postoperative 7 days	The primary outcome was the incidence of a composite endpoint of postoperative pulmonary complicationswithin 7 days after surgery. Postoperative pulmonary complications was considered to have occurred if at least one postoperative pulmonary event was observed, such as the pneumonia, pleural effusion, respiratory failure, hypoxemia, pneumothorax, atelectasis of the lung, bronchospasm..Ultrasound scans were performed at 20 min before starting mechanical ventilation of the lungs (before intubation) and performed at 20 min after surgery (after extubation)

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative deep venous thrombosis	Postoperative 7 days	Lower extremity venous ultrasound, preoperative and postoperative coagulation related values, blood routine, etc
Cardiac injury	Postoperative 7 days and 30 days	Myocardial injury was diagnosed when available troponin concentrations exceeded generation-specific and type-specific thresholds and were apparently of ischaemic origin (ie, no other obvious cause for artifactual elevation). We used the following thresholds based on available literature at time of adjudication: 1) non-high-sensitivity (fourth-generation) troponin T ≥0.03 ng/ml2; 2) high-sensitivity troponin T ≥65 ng/L; or high-sensitivity troponin T 20-64 ng/L and an increase ≥5 ng/L from baseline3; 3) high-sensitivity troponin I (Abbott assay) is ≥75 ng/L4; 4) high-sensitivity troponin I (Siemens assay) is ≥60 ng/L5; or, 5) troponin I (other assays) greater than local 99th percentiles. Myocardial infarction diagnosis required both troponin elevation and at least one diagnostic symptom or sign.
Postoperative pain	Postoperative 2 days and 7 days	Postoperative pain evaluated by 0-10-point numerical rating scale, with high scores indicating worse pain.
Overall complications	Postoperative 7 days and 30 days	Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, and bleeding from the surgery.
Postoperative mortality rate	Postoperative 7 days and 30 days	Follow-up by phone or mail for patient mortality.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China