PainNCT02262039
Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System
A study testing Valveless recirculating insufflation (VTI) and Conventional pressure in people with Pain, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Valveless recirculating insufflation (VTI) and Conventional pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any living donor who has been approved to donate a kidney is eligible to participate.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Transplantation Center
New Haven, Connecticut, 06520
About this study
Official title: Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Valveless recirculating insufflation (VTI), Conventional pressure
- Keywords
- living, kidney, donors
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valveless recirculating insufflation (VTI)Device
10 mmHg target pressure
Conventional pressureDevice
15 mmHg target pressure
| Study group | Role | What they receive |
|---|---|---|
| Conventional Pressure | Active comparator | Conventional Insufflation with 15mmHg target pressure Receives: Device: Conventional pressure |
| Low Pressure (VTI) | Experimental | Valveless recirculating insufflation (VTI) with 10mmHg target pressure Receives: Device: Valveless recirculating insufflation (VTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Measured: Intra-Operative on day of surgery
Narcotic Use (mg)
Total Morphine Equivalents - mean in mg
Measured: Post-operative (until time of discharge, typically 2-4 days)
Narcotic Use (mg)
Total Morphine Equivalent - mean in mg
Measured: Operative and Post-operative (until time of discharge, typically 2-4 days)
Secondary outcomes (4)
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.
Measured: 1 hour 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.
Measured: 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.
Measured: 12 hours post-op
Mean ETCO2
mean End-tidal carbon dioxide concentration in the expired air
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Responsible party
- Sponsor
- Investigators
- Sanjay Kulkarni, MD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262039
- Sponsor's protocol ID
- 1405013985
- Status last verified
- Jan 2018
- First submitted
- 9 Jul 2014
- Last updated
- 17 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02262039
- Acronym / sponsor ID
- 1405013985
- Conditions
- Pain
- Keywords
- living, kidney, donors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 23 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Pressure | Active comparator | Device: Conventional pressureConventional Insufflation with 15mmHg target pressure |
| Low Pressure (VTI) | Experimental | Device: Valveless recirculating insufflation (VTI)Valveless recirculating insufflation (VTI) with 10mmHg target pressure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any living donor who has been approved to donate a kidney is eligible to participate.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valveless recirculating insufflation (VTI)10 mmHg target pressure | Device | Low Pressure (VTI) |
| Conventional pressure15 mmHg target pressure | Device | Conventional Pressure |
Primary outcome
Narcotic Use (mg)
Time frame: Intra-Operative on day of surgery
Total Morphine Equivalents - mean in mg
Narcotic Use (mg)
Time frame: Post-operative (until time of discharge, typically 2-4 days)
Total Morphine Equivalents - mean in mg
Narcotic Use (mg)
Time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)
Total Morphine Equivalent - mean in mg
4 secondary outcomes
Subjective Pain Score
Time frame: 1 hour post-op
Subjective Pain Score
Time frame: 6 hours post-op
Subjective Pain Score
Time frame: 12 hours post-op
Mean ETCO2
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Kulkarni, MD study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valveless recirculating insufflation (VTI) and Conventional pressure in people with Pain, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Use (mg) (time frame: Intra-Operative on day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.