Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy

NCT05350137 | Completed Results DMC

• 1 other identifier: TJ-IRB20220140
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

With the increasing acceptance of routine computed tomography (CT) screenings, early-stage lung cancer detection is becoming more frequent. For ground glass opacity predominant early-stage lung cancer, segmentectomy can get the same oncological benefits as lobectomy. In addition, lung nodules that are highly suspected to be metastases can also be performed by segmentectomy to preserve more lung function. During the surgery, the rapid and precise identification of the intersegmental plane is one of the challenges. The improved inflation-deflation method is currently the most widely used method in clinical practice. According to the dispersion coefficient of the gas, the rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. The purpose of this study was to investigate the feasibility and safety of carbon dioxide on the appearance time of satisfactory and ideal planes during segmentectomy.

Conditions

Lung Cancer; Pulmonary Nodule, Solitary; Segmentectomy; Pulmonary Nodule, Multiple

Keywords

Lung segmentectomy; Intersegmental plane; Inflation-deflation method; Carbon dioxide

Outcome Measures

Primary Outcomes (1)

• The Intersegmental Border Appearance Time During the Surgery.

  The starting time point of the intersegmental plane was when the whole lungs had completely re-expanded. The end point was when the preserved segment was fully deflated, and a boundary had formed between the targeted segment and the reserved lung.

  The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons during the surgery.

Secondary Outcomes (1)

• The Arterial Blood Gas Results During Perioperative Period.

  Immediately after the radial arterial catheterization when inhaling the air, pre-intervention, 3-minutes, 5-minutes, 15-minutes during the single lung ventilation after the intervention.

Other Outcomes (3)

• The Incidence of Postoperative Complications.

  4 weeks after surgery.

• The Length of Hospital Stays.

  Up to 14 days.

• Quality of Recovery.

  Up to 7 days.

Study Arms (2)

Group A: 100% oxygen

ACTIVE COMPARATOR

After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.

Procedure: 100% oxygen

Group B: Carbon dioxide

EXPERIMENTAL

After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.

Procedure: Carbon dioxide

Interventions

100% oxygen PROCEDURE

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. Improved inflation-deflation method is currently the most widely used method in clinical practice. After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group A: 100% oxygen

Carbon dioxide PROCEDURE

During one-lung ventilation with an open chest, the non-ventilated lung collapses initially due to the inherent elastic recoil properties of the lung. Once passive venting has ceased, further collapse will then be wholly dependent on ongoing gaseous uptake and absorption atelectasis. The solubility coefficient for carbon dioxide is 0.57. The rapid diffusion properties of carbon dioxide would be expected to speed lung collapse and so facilitate surgery. After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. After the operative lungs is completely expanded, perform pure oxygen mechanical single lung ventilation for the healthy lung, waiting for clear presentation of the plane between the targeted segment and the other segments.

Group B: Carbon dioxide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Segmentectomy is feasible according to the reconstructed 3-dimensional (3D) images.
• Pulmonary nodule 2 cm or smaller in diameter with 50% or more ground-glass opacity (GGO) on thin-slice computed tomography, indicating an underlying malignancy.
• Ability to provide written informed consent.
• Unable to tolerate lobectomy as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation.
• Diagnosis confirmed or suspected of lung metastatic cancer.

You may not qualify if:

• Patients who are at risk for general anesthesia.
• Patients with serious mental illness.
• Pregnancy or lactating women.
• Active bacterial or fungal infections.
• Panties with Interstitial pneumonia, pulmonary fibrosis or severe emphysema.
• Conversion to thoracotomy in surgery.
• Preoperative assessment of patients undergoing lobectomy.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Interventions

Oxygen; Carbon Dioxide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Carbon Compounds, Inorganic; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Wei Ping
• Organization: Tongji Hospital affiliated Tongji Medical College of Huazhong University of Science and Technology

247046170@qq.com

+8613437101581

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: April 27, 2022
• Study Start: February 11, 2022
• Primary Completion: April 20, 2022
• Study Completion: May 11, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)