Actively Recruiting
Application of Atomized Inhalation ICG in Thoracoscopic Surgery for Pulmonary Sequestration in Children: a Multicentre Prospective Study
Led by Jiexiong Feng · Updated on 2024-10-16
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of using preoperative aerosol inhalation of Indocyanine Green (ICG) solution to improve thoracoscopic surgery for congenital lung malformations in children. This study focuses on children aged between 3 months and 14 years who have been diagnosed with congenital lung malformations, aiming to help surgeons accurately identify and remove affected lung tissue. Before surgery, children undergo pulmonary ventilation function evaluation and enhanced lung CT scans. Approximately 30 minutes before surgery, they inhale an ICG solution dissolved in saline at a dose of 0.5 mg/kg. During surgery, a fluorescence thoracoscope is used to clearly differentiate normal lung tissue from diseased tissue by fluorescence staining. The lesion boundaries are marked, and lung tissue is carefully dissected using specialized surgical tools. After removing the lesion, the surgical area is examined for bleeding or air leaks, followed by chest drainage tube placement. Participants are followed up 3 to 6 months after surgery with outpatient visits including pulmonary CT scans and lung function tests. Measurements such as tidal volume, inhalation/exhalation time ratio, peak time ratio, and peak volume ratio are compared before and after surgery. Researchers also monitor the rate of residual disease at 3 months and hospital stay length up to 14 days to assess outcomes and safety.
CONDITIONS
Brief Title
Atomized Inhalation ICG for Treatment of Congenital Lung Malformations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with congenital lung malformations diagnosed by CT or MRI scan
- Age between 3 months and 14 years
You will not qualify if you...
- Age less than 3 months or greater than 14 years
- Presence of other life-threatening diseases
- Severe pulmonary infection present at the time of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants inhale ICG solution 30 minutes before surgery. Thoracoscopic surgery is performed to remove lung lesions using fluorescence imaging to guide resection.
1 surgical visit (in-person)
Duration - 3 to 6 months
Participants undergo outpatient follow-up including pulmonary CT and ventilation function measurements to assess recovery and lung function.
1 to 2 outpatient visits
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
T
Tianqi Zhu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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