Trial Outcomes & Findings for Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies (NCT NCT02114164)

Results Overview

Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

Through end of procedure, an average of 156 minutes

Results posted on

2021-11-26

Participant Flow

9 participants withdrew from the study after providing informed consent but before being randomized to a group and receiving an intervention

Participant milestones

Participant milestones
Measure	AirSeal System This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data were not recorded for one patient in the Standard Endopath group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AirSeal System n=50 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=50 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.	Total n=100 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 5.6 • n=50 Participants	62.0 years STANDARD_DEVIATION 6.7 • n=50 Participants	61.5 years STANDARD_DEVIATION 6.2 • n=100 Participants
Sex: Female, Male Female	NA Participants n=50 Participants	NA Participants n=50 Participants	NA Participants n=100 Participants
Sex: Female, Male Male	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	50 Participants n=50 Participants	42 Participants n=50 Participants	92 Participants n=100 Participants
Race/Ethnicity, Customized Race/Ethnicity · African American	0 Participants n=50 Participants	7 Participants n=50 Participants	7 Participants n=100 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=50 Participants	1 Participants n=50 Participants	1 Participants n=100 Participants
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants
Body Mass Index (BMI)	29.1 kg/m^2 STANDARD_DEVIATION 4.3 • n=50 Participants • Data were not recorded for one patient in the Standard Endopath group.	28.3 kg/m^2 STANDARD_DEVIATION 3.3 • n=49 Participants • Data were not recorded for one patient in the Standard Endopath group.	28.7 kg/m^2 STANDARD_DEVIATION 3.8 • n=99 Participants • Data were not recorded for one patient in the Standard Endopath group.
Preoperative hemoglobin	15.1 g/dL STANDARD_DEVIATION 1.0 • n=50 Participants • Data not recorded for one participant in the Standard Endopath group	14.7 g/dL STANDARD_DEVIATION 1.0 • n=49 Participants • Data not recorded for one participant in the Standard Endopath group	14.8 g/dL STANDARD_DEVIATION 1.0 • n=99 Participants • Data not recorded for one participant in the Standard Endopath group
Preoperative creatinine	0.89 mg/dL STANDARD_DEVIATION 0.1 • n=50 Participants • Data not recorded for one participant in the Standard Endopath group	0.96 mg/dL STANDARD_DEVIATION 0.2 • n=49 Participants • Data not recorded for one participant in the Standard Endopath group	0.92 mg/dL STANDARD_DEVIATION 0.1 • n=99 Participants • Data not recorded for one participant in the Standard Endopath group

PRIMARY outcome

Timeframe: Through end of procedure, an average of 156 minutes

Population: Data were missing for one participant in each group.

Pneumoperitoneal pressure is the pressure exerted by air or gas in the abdominal (peritoneal) cavity. As the amount of air/gas increases, the pressure (mmHg) increases. The highest pressure that occurred during the procedure was compared between groups.

Outcome measures

Outcome measures
Measure	AirSeal System n=49 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Intraoperative Pneumoperitoneal Pressure (mmHg)	7.9 mmHg Standard Deviation 2.5	9.9 mmHg Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

Population: Data were missing for one participant in the Standard Endopath group at all time points. Data were missing for two AirSeal participants at baseline and 60 minutes, and for one AirSeal participant at end of procedure.

The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure

Outcome measures

Outcome measures
Measure	AirSeal System n=50 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). Baseline	39.5 mmHg Standard Deviation 4.9	39.2 mmHg Standard Deviation 5.3
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). 60 minutes	41.5 mmHg Standard Deviation 7.7	41.2 mmHg Standard Deviation 5.2
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). End of procedure	45.1 mmHg Standard Deviation 6.1	44.1 mmHg Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

Population: Missing data for five, five, and seven AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for five, four, and four participants at baseline, 60 minutes, and end of procedure, respectively.

End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg.

Outcome measures

Outcome measures
Measure	AirSeal System n=50 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
End-tidal Carbon Dioxide Pressure (mmHg) Baseline	31.47 mmHg Standard Deviation 3.9	29.96 mmHg Standard Deviation 3.1
End-tidal Carbon Dioxide Pressure (mmHg) 60 Minutes	32.80 mmHg Standard Deviation 3.6	30.96 mmHg Standard Deviation 3.2
End-tidal Carbon Dioxide Pressure (mmHg) End of procedure	34.77 mmHg Standard Deviation 8.9	34.17 mmHg Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes

Population: Missing data for eight, six, and nine AirSeal participants at baseline, 60 minutes, and end of procedure, respectively. Missing data for eight, seven, and eight Standard Endopath participants at baseline, 60 minutes, and end of procedure, respectively.

Carbon dioxide elimination was calculated using end-tidal carbon dioxide pressure (EtCO2), tidal volume, respiratory rate, barometric pressure (pB = 760mm Hg), partial pressure of water vapor (PH2O = 13 mm Hg), and patient weight (kg)

Outcome measures

Outcome measures
Measure	AirSeal System n=50 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Carbon Dioxide Elimination (mmHg) Baseline	3.15 mmHg Standard Deviation 0.67	3.28 mmHg Standard Deviation 0.64
Carbon Dioxide Elimination (mmHg) 60 minutes	3.24 mmHg Standard Deviation 0.74	3.28 mmHg Standard Deviation 0.6
Carbon Dioxide Elimination (mmHg) End of procedure	3.04 mmHg Standard Deviation 1.35	3.11 mmHg Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline, 60 minutes, and end of procedure, an average of 156 minutes

Population: Data missing for one Standard Endopath participant at all time points. Data missing for two AirSeal participants at baseline and 60 minutes, and one AirSeal participant at end of procedure.

The amount of dissolved oxygen (PaO2) in arterial blood (mmHg).

Outcome measures

Outcome measures
Measure	AirSeal System n=49 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Intraoperative Arterial Blood Gas Oxygen (mmHg). Baseline	361.9 mmHg Standard Deviation 79.3	364.3 mmHg Standard Deviation 81.9
Intraoperative Arterial Blood Gas Oxygen (mmHg). 60 minutes	283.9 mmHg Standard Deviation 115.4	294 mmHg Standard Deviation 105.0
Intraoperative Arterial Blood Gas Oxygen (mmHg). End of procedure	286.5 mmHg Standard Deviation 99.1	290.2 mmHg Standard Deviation 99.4

SECONDARY outcome

Timeframe: Through end of procedure, an average of 156 minutes

Population: Missing data for two participants in the AirSeal group and one participant in the Standard Endopath group

The number of times the anesthesiologist had to adjust ventilator settings

Outcome measures

Outcome measures
Measure	AirSeal System n=48 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Number of Ventilator Interventions	0.69 Count of interventions Standard Deviation 1.1	0.66 Count of interventions Standard Deviation 0.9

SECONDARY outcome

Timeframe: Through end of procedure, an average of 156 minutes

Population: Missing data for one participant in the AirSeal group and one participant in the Standard Endopath group

The duration of the procedure

Outcome measures

Outcome measures
Measure	AirSeal System n=49 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=49 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Procedure Time (Minutes)	158.6 Minutes Standard Deviation 22.4	153.0 Minutes Standard Deviation 19.9

SECONDARY outcome

Timeframe: Through end of procedure, an average of 156 minutes

Population: Missing data for one participant in the AirSeal group and two participants in the Standard Endopath group

Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average

Outcome measures

Outcome measures
Measure	AirSeal System n=49 Participants This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=48 Participants This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Smoke Evacuation Quality Below Average	4 Participants	16 Participants
Smoke Evacuation Quality Average	25 Participants	18 Participants
Smoke Evacuation Quality Above Average	20 Participants	14 Participants

Adverse Events

AirSeal System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard Endopath

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AirSeal System n=50 participants at risk This group receives the AirSeal System for intraoperative insufflation. AirSeal System: To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.	Standard Endopath n=50 participants at risk This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation.
Gastrointestinal disorders Nausea	2.0% 1/50 • Number of events 1 • Through hospital discharge, an average of 8.4 hours All patients were assessed through discharge for device malfunction, wound infection, urine output, nausea, and vomiting.	6.0% 3/50 • Number of events 3 • Through hospital discharge, an average of 8.4 hours All patients were assessed through discharge for device malfunction, wound infection, urine output, nausea, and vomiting.

Additional Information

Dr. Oscar Martinez

OhioHealth

Phone: (614) 544-8104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place