Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Children; Thoracoscopic Surgery; Indocyanine Green; Congenital Pulmonary Airway Malformation; Pulmonary Sequestration
• Intervention / Treatment: Procedure: atomized inhalation ICG before thoracoscope pneumonectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianqi Zhu, MD; Phone Number: 430000 0086-13986295423; Email: zhutianqi84@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICG for CLMs; 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. 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate residual	Residual lesions can usually only be found in postoperative radiology scan	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak volume ratio	Pulmonary function review ventilator-function indicators of peak volume ratio	3 months
length of hospital stay	length of hospital stay	up to 14 days
peak time ratio	Pulmonary function review ventilator-function indicators of peak time ratio	3 months

Collaborators and Investigators

• Sponsor: Jiexiong Feng
• Investigators: Principal Investigator: Tianqi Zhu, MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiratory System Abnormalities; Congenital Abnormalities; Cystic Adenomatoid Malformation of Lung, Congenital; Bronchopulmonary Sequestration
• Other Study ID Numbers: ICG-CLMs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No