Skull Base TumorNCT06587906
Postoperative Complications Following Skull Base Tumor Resection
An observational study of Skull Base Tumor and Postoperative Complications, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Base Tumor, Postoperative Complications
- What is being tested?
- Pulmonary ultrasound examination
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Age 18 and above
- American Society of Anesthesiologists physical status I to III
- Undergoing elective resection of skull base tumors
- Obtaining written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Yuming Peng
About this study
Official title: Postoperative Complications Following Skull Base Tumor Resection: an Observational Study
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.
Read the detailed description
- 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.
- Conditions
- Skull Base Tumor, Postoperative Complications
- Being tested
- Pulmonary ultrasound examination
- Medical subject headings
- Skull Base Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary ultrasound examinationOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Postoperative 7 days
Secondary outcomes (5)
The incidence of postoperative deep venous thrombosis
Lower extremity venous ultrasound, preoperative and postoperative coagulation related values, blood routine, etc
Measured: Postoperative 7 days
Cardiac injury
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.
Measured: Postoperative 7 days and 30 days
Postoperative pain
Postoperative pain evaluated by 0-10-point numerical rating scale, with high scores indicating worse pain.
Measured: Postoperative 2 days and 7 days
Overall complications
Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, and bleeding from the surgery.
Measured: Postoperative 7 days and 30 days
Postoperative mortality rate
Follow-up by phone or mail for patient mortality.
Measured: Postoperative 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Base TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587906
- Sponsor's protocol ID
- 2023009
- Status last verified
- Feb 2025
- First submitted
- 5 Sep 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications Following Skull Base Tumor Resection: an Observational Study
- ClinicalTrials.gov ID
- NCT06587906
- Acronym / sponsor ID
- 2023009
- Conditions
- Skull Base Tumor, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age 18 and above
- American Society of Anesthesiologists physical status I to III
- Undergoing elective resection of skull base tumors
- Obtaining written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary ultrasound examinationAll 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). | Other | – |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuming Peng study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Base Tumor and Postoperative Complications, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng (18601076588, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative pulmonary complications (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.