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NCT Number: NCT06587906

Postoperative Complications Following Skull Base Tumor Resection

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.

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Key information

Conditions

Skull Base Tumor Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skull Base Neoplasms Skull Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Yuming Peng

CONTACT

About this study

  • 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.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary ultrasound examination

Other

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).

Primary outcomes

  1. The incidence of postoperative pulmonary complications

    Time frame: 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 outcomes

  1. The incidence of postoperative deep venous thrombosis

    Time frame: Postoperative 7 days

    Lower extremity venous ultrasound, preoperative and postoperative coagulation related values, blood routine, etc

  2. Cardiac injury

    Time frame: 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.

  3. Postoperative pain

    Time frame: Postoperative 2 days and 7 days

    Postoperative pain evaluated by 0-10-point numerical rating scale, with high scores indicating worse pain.

  4. Overall complications

    Time frame: Postoperative 7 days and 30 days

    Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, and bleeding from the surgery.

  5. Postoperative mortality rate

    Time frame: Postoperative 7 days and 30 days

    Follow-up by phone or mail for patient mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zeng

CONTACT

[email protected]

15810617027

Yuming Peng

CONTACT

[email protected]

18601076588

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Postoperative Complications Following Skull Base Tumor Resection: an Observational Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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