Postoperative Complications Following Skull Base Tumor Resection

Postoperative Complications Following Skull Base Tumor Resection: an Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Skull Base Tumor
• Intervention / Treatment: Other: Pulmonary ultrasound examination

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 Type: Observational
• Enrollment (Estimated): 122

Contacts and Locations

• Study Contact: Name: Yuming Peng; Phone Number: 18601076588; Email: florapym766@163.com
• Study Contact Backup: Name: Min Zeng; Phone Number: 15810617027; Email: fly800727@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Contact: Yuming Peng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients aged 18 years and older, classified as American Society of Anesthesiologists physical status I to III, who are undergoing elective resection of skull base tumors and have obtained written informed consent will be included

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative pulmonary complications	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)	Postoperative 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality rate	Follow-up by phone or mail for patient mortality.	Postoperative 7 days and 30 days
The incidence of postoperative deep venous thrombosis	Lower extremity venous ultrasound, preoperative and postoperative coagulation related values, blood routine, etc	Postoperative 7 days
Cardiac injury	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 7 days and 30 days
Postoperative pain	Postoperative pain evaluated by 0-10-point numerical rating scale, with high scores indicating worse pain.	Postoperative 2 days and 7 days
Overall complications	Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, and bleeding from the surgery.	Postoperative 7 days and 30 days

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Yuming Peng, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Bone Neoplasms; Skull Neoplasms; Postoperative Complications; Skull Base Neoplasms
• Other Study ID Numbers: 2023009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No