Trial Outcomes & Findings for AirSeal®Insufflation Trocar/CO2 Absorption Study (NCT NCT02654808)
NCT ID: NCT02654808
Last Updated: 2021-09-16
Results Overview
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases \< 60 minutes, the CO2 absorption rate at 15 minutes will be used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
15 minutes & 60 minutes from surgery start time
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Standard Trocar/ IAP 15 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AirSeal®Insufflation Trocar/CO2 Absorption Study
Baseline characteristics by cohort
| Measure |
Standard Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 15 minutes & 60 minutes from surgery start timePopulation: 132 patients were enrolled and randomized into 1 of 4 study arms: standard insufflation/IAP 10 (S/10), standard insufflation/IAP 15 (S/15), valveless insufflation/IAP 10 (V/10), valveless insufflation/IAP 15 (V/15).
This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases \< 60 minutes, the CO2 absorption rate at 15 minutes will be used.
Outcome measures
| Measure |
Standard Trocar/ IAP 15 mmHg
n=31 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg
|
3.96 mL/(kg*min)
Standard Deviation 1.19
|
4.05 mL/(kg*min)
Standard Deviation 1.08
|
4.04 mL/(kg*min)
Standard Deviation 1.54
|
3.97 mL/(kg*min)
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: At the end of surgery (approximately 1 hour)Population: 132 patients were enrolled and randomized with 33 patients per arm. The participants were women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
Surgeon Questionnaire (0 "not adequate" -10 "optimal") is designed to evaluate the visualization of operative field by surgeon during colpotomy.
Outcome measures
| Measure |
Standard Trocar/ IAP 15 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=31 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Baseline
|
10.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
10.0 score on a scale from 0 to 10
Standard Deviation 1.0
|
10.0 score on a scale from 0 to 10
Standard Deviation 1.0
|
10.0 score on a scale from 0 to 10
Standard Deviation 0.8
|
|
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
At 15 minutes
|
8.0 score on a scale from 0 to 10
Standard Deviation 3.0
|
8.0 score on a scale from 0 to 10
Standard Deviation 4.0
|
10.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
10.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
|
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
At 30 minutes
|
8.0 score on a scale from 0 to 10
Standard Deviation 3.0
|
8.0 score on a scale from 0 to 10
Standard Deviation 3.0
|
9.0 score on a scale from 0 to 10
Standard Deviation 3.0
|
9.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
|
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Colpotomy
|
4.5 score on a scale from 0 to 10
Standard Deviation 4.0
|
5.0 score on a scale from 0 to 10
Standard Deviation 4.0
|
8.0 score on a scale from 0 to 10
Standard Deviation 4.0
|
9.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
|
Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars
Overall
|
7.0 score on a scale from 0 to 10
Standard Deviation 3.0
|
7.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
9.0 score on a scale from 0 to 10
Standard Deviation 2.0
|
9.5 score on a scale from 0 to 10
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: At the end of surgery (approximately 1 hour)Population: Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
Anesthesia Questionnaire (0 "no problem" - 2 "very problematic) is designed to evaluate the the level of difficulty in maintaining adequate end-tidal CO2 (etCO2).
Outcome measures
| Measure |
Standard Trocar/ IAP 15 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=31 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars
|
30 Participants
|
30 Participants
|
32 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 4 to 6 hours, and 12 to 23 hours following surgeryPopulation: Post-operative shoulder pain of women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
Visual Analog Scale (VAS) Pain Score (0 "no pain" - 10 "worst pain") is designed to evaluate the level of pain post-surgery.
Outcome measures
| Measure |
Standard Trocar/ IAP 15 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=31 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
PACU arrival
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
|
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
PACU discharge
|
0 score on a scale from 0 to 10
Standard Deviation 2
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 4
|
0 score on a scale from 0 to 10
Standard Deviation 1
|
|
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
Post-operative Day #1
|
0 score on a scale from 0 to 10
Standard Deviation 4
|
0 score on a scale from 0 to 10
Standard Deviation 4
|
0 score on a scale from 0 to 10
Standard Deviation 4
|
0 score on a scale from 0 to 10
Standard Deviation 5
|
|
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
4 to 6 hours
|
0 score on a scale from 0 to 10
Standard Deviation 5
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 9
|
|
Median VAS Pain Score When Using AirSeal® Versus Standard Trocars
12 to 23 hours
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 0
|
0 score on a scale from 0 to 10
Standard Deviation 2
|
1.5 score on a scale from 0 to 10
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 15 minutes & 60 minutes from surgery start timePopulation: Women ≥ 18 years old undergoing non-emergent conventional or robotic gynecologic laparoscopic surgery.
This outcome is measured by calculating the CO2 elimination rate.
Outcome measures
| Measure |
Standard Trocar/ IAP 15 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
Standard Trocar/ IAP 10 mmHg
n=31 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
Standard trocar: A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.
|
AirSeal Trocar/ IAP 15 mmHg
n=33 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
AirSeal Trocar/ IAP 10 mmHg
n=32 Participants
Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.
AirSeal trocar: The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.
|
|---|---|---|---|---|
|
Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg
|
4.05 mL/(kg*min)
Standard Deviation 1.08
|
3.96 mL/(kg*min)
Standard Deviation 1.19
|
3.97 mL/(kg*min)
Standard Deviation 1.00
|
4.04 mL/(kg*min)
Standard Deviation 1.54
|
Adverse Events
Standard Trocar/ IAP 15 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Trocar/ IAP 10 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AirSeal Trocar/ IAP 15 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AirSeal Trocar/ IAP 10 mmHg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place