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

Primary Purpose

Lung Cancer, Pulmonary Nodule, Solitary, Segmentectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
100% oxygen
Carbon dioxide
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung segmentectomy, Intersegmental plane, Inflation-deflation method, Carbon dioxide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-80 years of age.
  2. Segmentectomy is feasible according to the reconstructed 3-dimensional (3D) images.
  3. 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.
  4. Ability to provide written informed consent.
  5. Unable to tolerate lobectomy as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation.
  6. Diagnosis confirmed or suspected of lung metastatic cancer.

Exclusion Criteria:

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

Sites / Locations

  • Tongji hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: 100% oxygen

Group B: Carbon dioxide

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The arterial blood gas results during perioperative period.
Extracting arterial blood gas.

Full Information

First Posted
February 16, 2022
Last Updated
April 24, 2022
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05350137
Brief Title
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy
Official Title
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was approved by the ethics committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. This randomized parallel group trial enrolled patients scheduled to receive thoracoscopic anatomic segmentectomy at Tongji Hospital. General anesthesia with double lumen endotracheal tube was administered to the patients. With the guidance of preoperative three-dimensional computed tomography bronchography and angiography, the targeted segment structures could be precisely dissected, and then intersegmental demarcation was confirmed by the modified inflation-deflation method in this study. In group A (100% oxygen), after dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. In group B (Carbon dioxide), after the targeted segment structures were successfully dissected, the collapsed operative lung was completely re-expanded with carbon dioxide. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Pulmonary Nodule, Solitary, Segmentectomy, Pulmonary Nodule, Multiple
Keywords
Lung segmentectomy, Intersegmental plane, Inflation-deflation method, Carbon dioxide

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: 100% oxygen
Arm Type
Active Comparator
Arm Description
After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen.
Arm Title
Group B: Carbon dioxide
Arm Type
Experimental
Arm Description
After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.
Intervention Type
Procedure
Intervention Name(s)
100% oxygen
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Carbon dioxide
Intervention Description
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.
Primary Outcome Measure Information:
Title
The intersegmental border appearance time during the surgery.
Description
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.
Time Frame
The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons during the surgery.
Secondary Outcome Measure Information:
Title
The arterial blood gas results during perioperative period.
Description
Extracting arterial blood gas.
Time Frame
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 Pre-specified Outcome Measures:
Title
The incidence of postoperative complications.
Description
Record the complications.
Time Frame
4 weeks after surgery.
Title
The length of hospital stays.
Description
Duration of hospitalization after surgery.
Time Frame
Up to 14 days.
Title
Quality of Recovery.
Description
Measured using the Quality of Recovery 40 (QoR-40) Score and asking patients to complete the questions 24 hours before operation, 48 hours after operation and 1 week after operation.
Time Frame
Up to 7 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ni Zhang, Doctor
Phone
+8613006315393
Email
zhangnidoc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Biyun Zhou, Doctor
Phone
+8613517275908
Email
biyun.zz@gmail.com
Facility Information:
Facility Name
Tongji hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ping, Doctor
Phone
+8613437101581
Email
247046170@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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