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Recruiting NCT06587906

Postoperative Complications Following Skull Base Tumor Resection

Observational Skull Base Tumor Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary ultrasound examination.
Who it may be relevant to
Registry conditions: Skull Base Tumor, Postoperative Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Postoperative Complications Following Skull Base Tumor Resection: an Observational Study

Overview

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

  • Other Pulmonary 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 examin

Primary outcome measures

  • The incidence of postoperative pulmonary complications [Time frame: Postoperative 7 days]
Secondary outcome measures (5)
  • The incidence of postoperative deep venous thrombosis [Time frame: Postoperative 7 days]
  • Cardiac injury [Time frame: Postoperative 7 days and 30 days]
  • Postoperative pain [Time frame: Postoperative 2 days and 7 days]
  • Overall complications [Time frame: Postoperative 7 days and 30 days]
  • Postoperative mortality rate [Time frame: Postoperative 7 days and 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06587906 · 2023009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗