Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

Children Clinical Trial

Official title:

Application of Atomized Inhalation ICG in Thoracoscopic Surgery for Pulmonary Sequestration in Children: a Multicentre Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302985
• Other study ID #: ICG-CLMs
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2050

Study information

• Verified date: March 2024
• Source: Tongji Hospital
• Contact: Tianqi Zhu, MD
• Phone: 0086-13986295423
• Email: zhutianqi84[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children.

Description:

Preoperative preparation Preoperative evaluation of pulmonary ventilation function and enhanced CT examination of the lungs were performed. Respiratory symptoms should be improved first in case of complicated respiratory infection. ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery.

Operation method Intraoperative fluorescence thoracoscopic imaging was used, and focal resection was performed. All patients were placed in lateral decubitus position under general anesthesia, and single lung ventilation was selected. A low flow rate (1-2 L/min) and low CO2 pressure (4-5 mmHg) were maintained in the thorax to establish an artificial pneumothorax. The observation hole is in the 7th or 8th intercostal space of the midaxillary line, and the two operating holes are in the 4th or 5th intercostal space of the anterior axillary line and the 8th or 9th intercostal space of the posterior axillary line, respectively. 30 degrees 10 mm fluorescence thoracoscope. After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed. Smaller blood vessels could be cut by Ligasure or ultrasonic knife directly, and thicker blood vessels and bronchi should be cut by Hemolock until the lesion resection was completed. After the lesion was removed, the chest was rinsed with warm normal saline, and the lung tissue section was carefully examined to confirm that there was no active bleeding and air leakage, and the lung was well dilated. The intercostal nerve was blocked under thoracoscopic vision. Finally, the thoracic closed drainage tube was placed in the midaxillary line puncture hole and the incision was closed.

Post-operation follow-up All patients undergo outpatient follow-up 3-6 months after surgery, including pulmonary CT and pulmonary ventilation function measurements, and comparison of VT (tidal volume), Ti/Te suction/exhalation time ratio, TPTEF/TE (peak time ratio) and VPEF/VE (peak volume ratio) before and after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 14 Years

Eligibility

Inclusion Criteria:

• children with congenital lung malformations diagnosed by CT or MRI scan

Exclusion Criteria:

• 1. ages <3 months and >14 years 2. complicated other life-threatening disease; 3. complicated severely pulmonary infection

Related Conditions & MeSH terms

• Children
• Congenital Abnormalities
• Indocyanine Green
• Thoracoscopic Surgery

Intervention

Procedure:
• atomized inhalation ICG before thoracoscope pneumonectomy
Preoperative preparation ICG solution dissolved in 5ml of normal saline (dose 0.5mg/kg) was inhaled 30 minutes before surgery. Operation method After entering the chest cavity, the fluorescence endoscope was switched to the fluorescence display mode, and the fluorescence-stained normal lung tissue and non-stained lesion tissue could be clearly displayed through the display screen, and the external boundary of the lesion was marked with an electric hook. The mediastinal pleura and pulmonary pleura were opened along the boundary of the lesion, and the lung tissue was split along the gap between the lesion and the lung tissue with an electric coagulation hook and an ultrasonic knife, and the lesion arteries and bronchi were freed.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiexiong Feng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate residual	Residual lesions can usually only be found in postoperative radiology scan	3 months
Secondary	peak volume ratio	Pulmonary function review ventilator-function indicators of peak volume ratio	3 months
Secondary	length of hospital stay	length of hospital stay	up to 14 days
Secondary	peak time ratio	Pulmonary function review ventilator-function indicators of peak time ratio	3 months