Trial Outcomes & Findings for Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial (NCT NCT04302350)
NCT ID: NCT04302350
Last Updated: 2023-03-02
Results Overview
The starting point of intraoperative expansion and collapse observation is the time when the lung tissue is completely expanded after blocking the relevant structure of the target segment; the end point is when a clear demarcation is formed between the target segment and the immediately-reserved lung segment, and this boundary does not follow significant changes over time), and the time was recorded in seconds (S).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons
Results posted on
2023-03-02
Participant Flow
Three patients were excluded (1 refused to participate in the trial and 2 did not meet the inclusion criteria).
Participant milestones
| Measure |
Group75
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group50
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group50 set to N2O:O2=4:4). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group0
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group0 set to O2=8). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
23
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
8
|
Reasons for withdrawal
| Measure |
Group75
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group50
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group50 set to N2O:O2=4:4). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group0
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group0 set to O2=8). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group75
n=24 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group50
n=23 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group50 set to N2O:O2=4:4). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group0
n=18 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group0 set to O2=8). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.04 years
STANDARD_DEVIATION 9.56 • n=24 Participants
|
52.52 years
STANDARD_DEVIATION 10.86 • n=23 Participants
|
50.50 years
STANDARD_DEVIATION 13.24 • n=18 Participants
|
52.35 years
STANDARD_DEVIATION 11.22 • n=65 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=24 Participants
|
19 Participants
n=23 Participants
|
12 Participants
n=18 Participants
|
46 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=18 Participants
|
19 Participants
n=65 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
24 Participants
n=24 Participants
|
23 Participants
n=23 Participants
|
18 Participants
n=18 Participants
|
65 Participants
n=65 Participants
|
|
body mass index (BMI)
|
22.95 kg/m^2
STANDARD_DEVIATION 3.04 • n=24 Participants
|
21.61 kg/m^2
STANDARD_DEVIATION 3.30 • n=23 Participants
|
22.33 kg/m^2
STANDARD_DEVIATION 2.38 • n=18 Participants
|
22.29 kg/m^2
STANDARD_DEVIATION 2.90 • n=65 Participants
|
PRIMARY outcome
Timeframe: The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeonsThe starting point of intraoperative expansion and collapse observation is the time when the lung tissue is completely expanded after blocking the relevant structure of the target segment; the end point is when a clear demarcation is formed between the target segment and the immediately-reserved lung segment, and this boundary does not follow significant changes over time), and the time was recorded in seconds (S).
Outcome measures
| Measure |
Group75
n=24 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group50
n=23 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group50 set to N2O:O2=4:4). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group0
n=18 Participants
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group0 set to O2=8). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
|---|---|---|---|
|
The Intersegmental Border Appearance Time During the Surgery
|
320.20 seconds
Standard Deviation 65.89
|
552.39 seconds
Standard Deviation 88.96
|
968.33 seconds
Standard Deviation 85.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks after surgery.Recording duration of surgery, the incidence of postoperative complications (including air leak, chylothorax, atelectasis, pulmonary embolism, pulmonary infection), total thoracic drainage, duration of drainage and postoperative hospital stay.
Outcome measures
Outcome data not reported
Adverse Events
Group75
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group50
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group0
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group75
n=24 participants at risk
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group50
n=23 participants at risk
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group50 set to N2O:O2=4:4). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
Group0
n=18 participants at risk
The target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. The portable nitrous oxide concentration detector (TD600-SH-B-N2O, tiandi shouhe, Beijing, Chi-na) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group0 set to O2=8). When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. FiO2=1.0 was performed after the initiation of the OLV.
nitrous oxide: The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
intraoperative SPO2<90%
|
0.00%
0/24 • After the patients finished the operation two weeks later
Had intraoperative SPO2\<90% during the perioperative period
|
4.3%
1/23 • Number of events 1 • After the patients finished the operation two weeks later
Had intraoperative SPO2\<90% during the perioperative period
|
11.1%
2/18 • Number of events 2 • After the patients finished the operation two weeks later
Had intraoperative SPO2\<90% during the perioperative period
|
Additional Information
Dr.cunming Liu
The First Affiliated Hospital of Nanjing Medical University
Phone: 13951890866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place