Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SurgiQuest, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
The primary observation to be made is the level of carbon dioxide in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirSeal System | Active Comparator | This group receives the AirSeal System for intraoperative insufflation. |
|
| Standard Endopath | Active Comparator | This group receives the Standard Endopath Trocar for intraoperative insufflation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSeal System | Device | To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Pneumoperitoneal Pressure (mmHg) | 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. | Through end of procedure, an average of 156 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
| End-tidal Carbon Dioxide Pressure (mmHg) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronney Abaza, MD,FACS | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin Methodist Hospital | Columbus | Ohio | 43016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33349135 | Derived | Abaza R, Martinez O, Murphy C. Randomized Controlled Comparison of Valveless Trocar (AirSeal) vs Standard Insufflator with Ultralow Pneuomoperitoneum During Robotic Prostatectomy. J Endourol. 2021 Jul;35(7):1020-1024. doi: 10.1089/end.2020.1025. Epub 2021 Jan 21. |
Not provided
Not provided
9 participants withdrew from the study after providing informed consent but before being randomized to a group and receiving an intervention
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Endopath | This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Endopath |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Pneumoperitoneal Pressure (mmHg) | 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. | Data were missing for one participant in each group. | Posted | Mean | Standard Deviation | mmHg | Through end of procedure, an average of 156 minutes |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oscar Martinez | OhioHealth | (614) 544-8104 | oscar.martinez@ohiohealth.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2020 | Aug 4, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Endopath | Device | This group receives the Standard Endopath Trocar for intraoperative insufflation. |
|
|
End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg. |
| Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
| Carbon Dioxide Elimination (mmHg) | 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) | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
| Intraoperative Arterial Blood Gas Oxygen (mmHg). | The amount of dissolved oxygen (PaO2) in arterial blood (mmHg). | Baseline, 60 minutes, and end of procedure, an average of 156 minutes |
| Number of Ventilator Interventions | The number of times the anesthesiologist had to adjust ventilator settings | Through end of procedure, an average of 156 minutes |
| Procedure Time (Minutes) | The duration of the procedure | Through end of procedure, an average of 156 minutes |
| Smoke Evacuation Quality | Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average | Through end of procedure, an average of 156 minutes |
This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Data were not recorded for one patient in the Standard Endopath group. | Mean | Standard Deviation | kg/m^2 |
|
| Preoperative hemoglobin | Data not recorded for one participant in the Standard Endopath group | Mean | Standard Deviation | g/dL |
|
| Preoperative creatinine | Data not recorded for one participant in the Standard Endopath group | Mean | Standard Deviation | mg/dL |
|
This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation. |
|
|
|
| Secondary | Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg). | The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | End-tidal Carbon Dioxide Pressure (mmHg) | End-tidal carbon dioxide pressure is the partial pressure of carbon dioxide at the end of exhalation. Normal value is 35-45 mmHg. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | Carbon Dioxide Elimination (mmHg) | 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) | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 60 minutes, and at end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | Intraoperative Arterial Blood Gas Oxygen (mmHg). | The amount of dissolved oxygen (PaO2) in arterial blood (mmHg). | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 60 minutes, and end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | Number of Ventilator Interventions | The number of times the anesthesiologist had to adjust ventilator settings | Missing data for two participants in the AirSeal group and one participant in the Standard Endopath group | Posted | Mean | Standard Deviation | Count of interventions | Through end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | Procedure Time (Minutes) | The duration of the procedure | Missing data for one participant in the AirSeal group and one participant in the Standard Endopath group | Posted | Mean | Standard Deviation | Minutes | Through end of procedure, an average of 156 minutes |
|
|
|
|
| Secondary | Smoke Evacuation Quality | Smoke evacuation quality throughout the procedure was assessed by the surgeon as below average, average, or above average | Missing data for one participant in the AirSeal group and two participants in the Standard Endopath group | Posted | Count of Participants | Participants | Through end of procedure, an average of 156 minutes |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Standard Endopath | This group receives the Standard Endopath Trocar for intraoperative insufflation. Standard Endopath: This group receives the Standard Endopath Trocar for intraoperative insufflation. | 0 | 50 | 0 | 50 | 3 | 50 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| Other |
|
| 60 minutes |
|
|
| End of procedure |
|
|
| 60 Minutes |
|
|
| End of procedure |
|
|
Comparison at 60 minutes |
| Other |
| t-test, 2 sided | 0.712 | Comparison at end of procedure | Other |
| 60 minutes |
|
|
| End of procedure |
|
|
Comparison at 60 minutes |
| Other |
| t-test, 2 sided | 0.99 | Comparison at end of procedure | Other |
| 60 minutes |
|
|
| End of procedure |
|
|
Comparison at 60 minutes |
| Other |
| t-test, 2 sided | 0.86 | Comparison at end of procedure | Other |
| Above Average |
|