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| Name | Class |
|---|---|
| SurgiQuest, Inc. | INDUSTRY |
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The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.
Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.
The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Pressure | Active Comparator | Conventional Insufflation with 15mmHg target pressure |
|
| Low Pressure (VTI) | Experimental | Valveless recirculating insufflation (VTI) with 10mmHg target pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valveless recirculating insufflation (VTI) | Device | 10 mmHg target pressure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Intra-Operative on day of surgery |
| Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Post-operative (until time of discharge, typically 2-4 days) |
| Narcotic Use (mg) | Total Morphine Equivalent - mean in mg | Operative and Post-operative (until time of discharge, typically 2-4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Pain Score | Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain. | 1 hour post-op |
| Subjective Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Kulkarni, MD | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Transplantation Center | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Pressure | 15mmHg target pressure |
| FG001 | Low Pressure (VTI) | 10mmHg target pressure VTI = Valveless recirculating insufflation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who agreed to participate completed the study and are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Pressure | 15mmHg target pressure |
| BG001 | Low Pressure (VTI) | 10mmHg target pressure VTI= Valveless recirculating insufflation |
| 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 | Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Posted | Mean | Standard Deviation | mg | Intra-Operative on day of surgery |
|
|
1 month
Systematic chart reviews were conducted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Pressure | 15mmHg target pressure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative hemorrhage | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Kulkarni | Yale University | 203-785-6501 | sanjay.kulkarni@yale.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Conventional pressure |
| Device |
15 mmHg target pressure |
|
Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain. |
| 6 hours post-op |
| Subjective Pain Score | Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain. | 12 hours post-op |
| Mean ETCO2 | mean End-tidal carbon dioxide concentration in the expired air | intraoperative |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Nephrectomy Laterality | This refers to the location (left side vs. right side) of the kidney removed during the donor surgery | Number | participants |
|
| ASA Class | American Society of Anesthesiologists: ASA physical status classification system to assess fitness of patients before surgery. Classifications range from 1 (Healthy Person) to 6 (Declared brain-dead) Only participants in groups 1 and 2 (Healthy or mild systemic disease) are eligible to become living kidney donors. | Number | participants |
|
|
|
|
| Primary | Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Posted | Mean | Standard Deviation | mg | Post-operative (until time of discharge, typically 2-4 days) |
|
|
|
|
| Primary | Narcotic Use (mg) | Total Morphine Equivalent - mean in mg | Posted | Mean | Standard Deviation | mg | Operative and Post-operative (until time of discharge, typically 2-4 days) |
|
|
|
|
| Secondary | Subjective Pain Score | Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain. | Posted | Mean | Standard Deviation | units on a scale | 1 hour post-op |
|
|
|
|
| Secondary | Subjective Pain Score | Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain. | Posted | Mean | Standard Deviation | units on a scale | 6 hours post-op |
|
|
|
|
| Secondary | Subjective Pain Score | Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain. | Posted | Mean | Standard Deviation | units on a scale | 12 hours post-op |
|
|
|
|
| Secondary | Mean ETCO2 | mean End-tidal carbon dioxide concentration in the expired air | Posted | Mean | Standard Deviation | mmHg | intraoperative |
|
|
|
|
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | Low Pressure (VTI) | 10mmHg target pressure VTI= Valveless recirculating insufflation | 0 | 27 | 2 | 27 |
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
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