Clinical trial NCT06587906: Postoperative Complications Following Skull Base Tumor Resection
Official title: Postoperative Complications Following Skull Base Tumor Resection: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skull Base Tumor
Postoperative Complications
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: The incidence of postoperative pulmonary complications
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: The incidence of postoperative deep venous thrombosis
timeFrame: Postoperative 7 days
measure: Cardiac injury
timeFrame: Postoperative 7 days and 30 days
measure: Postoperative pain
timeFrame: Postoperative 2 days and 7 days
measure: Overall complications
timeFrame: Postoperative 7 days and 30 days
measure: Postoperative mortality rate
timeFrame: Postoperative 7 days and 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yuming Peng
role: STUDY_CHAIR
References: