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Postoperative Complications Following Skull Base Tumor Resection

Postoperative Complications Following Skull Base Tumor Resection: an Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06587906
Enrollment
122
Registered
2024-09-19
Start date
2024-09-10
Completion date
2027-09-01
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Skull Base Tumor

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.

Interventions

OTHERPulmonary ultrasound examination

All ultrasound scans were performed by the same anaesthetists. Pulmonary ultrasound examination was performed at two time points for each patient: 20 min before starting mechanical ventilation of the lungs when patients were placed in the supine position(preoperative), 20 min after after surgery end at the time the patient was placed in the supine position (postoperative), before Intubation and after extubation Patientswere scanned in the supine position following the pulmonary ultrasound examination method The thorax was divided by the anterior axillary line, the posterior axillary line, and a horizontal line beneath nipple. Twelve intercostal spaces of each area were scanned and analysed. Aeration loss was assessedby calculating the modified LUS score that is calculated mainly using the amount of B-line The pulmonary ultrasound score of the hemithorax (0-18).

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative pulmonary complicationsPostoperative 7 daysThe 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

MeasureTime frameDescription
The incidence of postoperative deep venous thrombosisPostoperative 7 daysLower extremity venous ultrasound, preoperative and postoperative coagulation related values, blood routine, etc
Cardiac injuryPostoperative 7 days and 30 daysMyocardial 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 painPostoperative 2 days and 7 daysPostoperative pain evaluated by 0-10-point numerical rating scale, with high scores indicating worse pain.
Overall complicationsPostoperative 7 days and 30 daysSurgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, and bleeding from the surgery.
Postoperative mortality ratePostoperative 7 days and 30 daysFollow-up by phone or mail for patient mortality.

Countries

China

Contacts

Primary ContactYuming Peng
florapym766@163.com18601076588
Backup ContactMin Zeng
fly800727@163.com15810617027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026