- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350137
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy
June 15, 2023 updated by: Zhang Ni, Tongji Hospital
Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ni Zhang, Doctor
- Phone Number: +8613006315393
- Email: zhangnidoc@163.com
Study Contact Backup
- Name: Biyun Zhou, Doctor
- Phone Number: +8613517275908
- Email: biyun.zz@gmail.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Experimental: Group B: Carbon dioxide
After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Intersegmental Border Appearance Time During the Surgery.
Time Frame: The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Arterial Blood Gas Results During Perioperative Period.
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.
|
Extracting arterial blood gas.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Recovery.
Time Frame: Up to 7 days.
|
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.
|
Up to 7 days.
|
The Incidence of Postoperative Complications.
Time Frame: 4 weeks after surgery.
|
Record the complications.
|
4 weeks after surgery.
|
The Length of Hospital Stays.
Time Frame: Up to 14 days.
|
Duration of hospitalization after surgery.
|
Up to 14 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2022
Primary Completion (Actual)
April 20, 2022
Study Completion (Actual)
May 11, 2022
Study Registration Dates
First Submitted
February 16, 2022
First Submitted That Met QC Criteria
April 24, 2022
First Posted (Actual)
April 27, 2022
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB20220140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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