Trial Outcomes & Findings for Application of Carbon Dioxide for Identifying the Intersegmental Plane in Thoracoscopic Segmentectomy (NCT NCT05350137)

Last Updated: 2024-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

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

Results posted on

2024-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Group B: Carbon Dioxide After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. 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.
Overall Study STARTED	26	26
Overall Study COMPLETED	23	18
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: 100% Oxygen n=23 Participants After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 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.	Group B: Carbon Dioxide n=18 Participants After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. 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.	Total n=41 Participants Total of all reporting groups
Age, Continuous	51.00 years STANDARD_DEVIATION 13.19 • n=5 Participants	51.17 years STANDARD_DEVIATION 12.48 • n=7 Participants	51.07 years STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	23 participants n=5 Participants	18 participants n=7 Participants	41 participants n=5 Participants
body mass index (BMI)	22.6 kg/m^2 STANDARD_DEVIATION 2.9 • n=5 Participants	23.8 kg/m^2 STANDARD_DEVIATION 3.0 • n=7 Participants	23.1 kg/m^2 STANDARD_DEVIATION 3.0 • n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Group A: 100% Oxygen n=23 Participants After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 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.	Group B: Carbon Dioxide n=18 Participants After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. 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.
The Intersegmental Border Appearance Time During the Surgery.	748.74 seconds Standard Deviation 177.16	157.11 seconds Standard Deviation 76.75

SECONDARY outcome

Timeframe: 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 events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A: 100% Oxygen n=23 participants at risk After dividing all the targeted vascular and bronchial structures, the lung of the operating side was re-inflated with 100% oxygen. 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.	Group B: Carbon Dioxide n=18 participants at risk After the targeted segment structures were successfully dissected, the collapsed intraoperative lung was completely re-expanded with carbon dioxide. 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.
Respiratory, thoracic and mediastinal disorders Air leakage	13.0% 3/23 • 4 weeks after surgery	11.1% 2/18 • 4 weeks after surgery
Respiratory, thoracic and mediastinal disorders Pneumonia	4.3% 1/23 • 4 weeks after surgery	5.6% 1/18 • 4 weeks after surgery
Cardiac disorders Atrial fibrillation	4.3% 1/23 • 4 weeks after surgery	0.00% 0/18 • 4 weeks after surgery

Additional Information

Dr. Wei Ping

Tongji Hospital affiliated Tongji Medical College of Huazhong University of Science and Technology

Phone: +8613437101581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place