Postoperative Complications Following Skull Base Tumor Resection

NCT06587906 | Recruiting DMC

• 1 other identifier: 2023009
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Base Tumor; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The incidence of postoperative deep venous thrombosis

  Postoperative 7 days

• Cardiac injury

  Postoperative 7 days and 30 days

• Postoperative pain

  Postoperative 2 days and 7 days

• Overall complications

  Postoperative 7 days and 30 days

• Postoperative mortality rate

  Postoperative 7 days and 30 days

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18 and above
• American Society of Anesthesiologists physical status I to III
• Undergoing elective resection of skull base tumors
• Obtaining written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Skull Base Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuming Peng

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Yuming Peng

CONTACT

18601076588; florapym766@163.com

Min Zeng

CONTACT

15810617027; fly800727@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)