Prostate CancerNCT02114164
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies
A study testing AirSeal System and Standard Endopath in people with Prostate Cancer and Pneumoperitoneum, run by OhioHealth at 1 site in United States.
Trial summary
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Pneumoperitoneum
- What is being tested?
- AirSeal System and Standard Endopath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 15 Jul 2019
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18
- Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital
Who cannot join
- Age < 18
- Emergency surgery
- Ascites
- BMI>44 or <18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Pneumoperitoneum
- Being tested
- AirSeal System, Standard Endopath
- Keywords
- AirSeal, Trocar, Carbon Dioxide Exchange and Absorption
- Medical subject headings
- Prostatic Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSeal SystemDevice
Also called Valve-free Trocar
To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
Standard EndopathDevice
Also called Endopath Trocar
This group receives the Standard Endopath Trocar for intraoperative insufflation.
| Study group | Role | What they receive |
|---|---|---|
| AirSeal System | Active comparator | This group receives the AirSeal System for intraoperative insufflation. Receives: Device: AirSeal System |
| Standard Endopath | Active comparator | This group receives the Standard Endopath Trocar for intraoperative insufflation. Receives: Device: Standard Endopath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through end of procedure, an average of 156 minutes
Secondary outcomes (7)
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).
The amount of dissolved carbon dioxide (PaCO2) in arterial blood (mmHg) during the operative procedure
Measured: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
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.
Measured: 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)
Measured: 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).
Measured: 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
Measured: Through end of procedure, an average of 156 minutes
Procedure Time (Minutes)
The duration of the procedure
Measured: 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
Measured: Through end of procedure, an average of 156 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startAug 2016
- Primary completion3 May 2018
- Study completion15 Jul 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Responsible party
- Sponsor
- Investigators
- Ronney Abaza, MD,FACS, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114164
- Sponsor's protocol ID
- OH1-13-00489
- Status last verified
- Oct 2021
- First submitted
- 10 Jan 2014
- Last updated
- 26 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33349135
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of CO2 Exchange Patterns Between Valve-free Trocar (AirSeal®) Versus Standard Trocar (Endopath®) During Robotic Prostatectomies
- ClinicalTrials.gov ID
- NCT02114164
- Acronym / sponsor ID
- OH1-13-00489
- Conditions
- Prostate Cancer, Pneumoperitoneum
- Keywords
- AirSeal, Trocar, Carbon Dioxide Exchange and Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- SurgiQuest, Inc.
- Study start
- Aug 2016
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 26 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AirSeal System | Active comparator | Device: AirSeal SystemThis group receives the AirSeal System for intraoperative insufflation. |
| Standard Endopath | Active comparator | Device: Standard EndopathThis group receives the Standard Endopath Trocar for intraoperative insufflation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18
- Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital
Key exclusion criteria (4 listed)
- Age < 18
- Emergency surgery
- Ascites
- BMI>44 or <18
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 |
|---|---|---|
| AirSeal SystemAlso: Valve-free TrocarTo analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar. | Device | AirSeal System |
| Standard EndopathAlso: Endopath TrocarThis group receives the Standard Endopath Trocar for intraoperative insufflation. | Device | Standard Endopath |
Primary outcome
Intraoperative Pneumoperitoneal Pressure (mmHg)
Time frame: Through end of procedure, an average of 156 minutes
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.
7 secondary outcomes
Intraoperative Arterial Blood Gas Carbon Dioxide (mmHg).
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
End-tidal Carbon Dioxide Pressure (mmHg)
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Carbon Dioxide Elimination (mmHg)
Time frame: Baseline, 60 minutes, and at end of procedure, an average of 156 minutes
Intraoperative Arterial Blood Gas Oxygen (mmHg).
Time frame: Baseline, 60 minutes, and end of procedure, an average of 156 minutes
Number of Ventilator Interventions
Time frame: Through end of procedure, an average of 156 minutes
Procedure Time (Minutes)
Time frame: Through end of procedure, an average of 156 minutes
Smoke Evacuation Quality
Time frame: Through end of procedure, an average of 156 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33349135Abaza 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.
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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.
Ronney Abaza, MD,FACS principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirSeal System and Standard Endopath in people with Prostate Cancer and Pneumoperitoneum, run by OhioHealth 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 2 inclusion and 4 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 26 Nov 2021. 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 26 Nov 2021). 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?
Intraoperative Pneumoperitoneal Pressure (mmHg) (time frame: Through end of procedure, an average of 156 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114164, which also lists 1 linked publication.
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 26 Nov 2021.