Shoulder PainPRESSURENCT02541448
Pneumoperitoneum Management With SurgiQuest AirSeal at Low vs. Higher Pressure ( PRESSURE )
A study testing SurgiQuest AIRSEAL® Insufflation System (AIS) in people with Shoulder Pain, run by Cynthia Harris at 1 site in United States.
Trial summary
This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- SurgiQuest AIRSEAL® Insufflation System (AIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 12 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;
Who cannot join
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus
- Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- Severe co-existing morbidities having a life expectancy of less than 30 days;
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- Currently involved in any other investigational clinical Studies;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
- Patients presenting with Ascites -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related to the Use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at Low VS. Higher Pressure for the Management of Pneumoperitoneum.
This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum.
Read the detailed description
The objective of this study is to evaluate physician preferences related to use of the SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures.
The study is designed and powered to demonstrate superiority of the AIS used at low insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an insufflation target pressure of 15±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, procedure time, the number of procedure interruptions, length of hospital stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse events. These outcomes will be evaluated in a controlled population undergoing laparoscopic/robotic surgery.
- Conditions
- Shoulder Pain
- Being tested
- SurgiQuest AIRSEAL® Insufflation System (AIS)
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiQuest AIRSEAL® Insufflation System (AIS)Device
Also called AIS
The SurgiQuest AirSeal Optical Trocar \& Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
| Study group | Role | What they receive |
|---|---|---|
| AIS at 9±1mmHg | Active comparator | Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg Receives: Device: SurgiQuest AIRSEAL® Insufflation System (AIS) |
| AIS at 15±1mmHg | Active comparator | Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 15±1mmHg. Receives: Device: SurgiQuest AIRSEAL® Insufflation System (AIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shoulder pain
Incidence of reported shoulder pain
Measured: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion18 May 2016
- Study completion12 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Harris
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SurgiQuest, Inc.
- Responsible party
- Sponsor-investigator, Cynthia Harris, SurgiQuest, Inc.
- Investigators
- John P Diaz, MD, Principal investigator, South Miami Hospital, Miami Floridaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541448
- Sponsor's protocol ID
- PRT DD030316
- Acronym
- PRESSURE
- Status last verified
- Nov 2019
- First submitted
- 1 Sep 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related to the Use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at Low VS. Higher Pressure for the Management of Pneumoperitoneum.
- ClinicalTrials.gov ID
- NCT02541448
- Acronym / sponsor ID
- PRESSURE / PRT DD030316
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Cynthia HarrisIndustry (pharma, biotech, devices)
- Collaborators
- SurgiQuest, Inc.
- Study start
- Jul 2015 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate physician preference related to the use of the SURGIQUEST AIRSEAL® INSUFFLATION SYSTEM (AIS) at low verses high pressure for the management of pneumoperitoneum.
Detailed description
The objective of this study is to evaluate physician preferences related to use of the SurgiQuest AirSeal Insufflation System (AIS) used at low vs. higher pressures for maintaining pneumoperitoneum during laparoscopic/robotic surgical procedures.
The study is designed and powered to demonstrate superiority of the AIS used at low insufflation pressure (9±mmHg ±1mmHg) vs higher pressure (15mmHg ±1mmHg) in relation to a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9±1mmHg) or to AIS with an insufflation target pressure of 15±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, procedure time, the number of procedure interruptions, length of hospital stay, aspects of anesthesia management including end tidal CO2 and the frequency of adverse events. These outcomes will be evaluated in a controlled population undergoing laparoscopic/robotic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS at 9±1mmHg | Active comparator | Device: SurgiQuest AIRSEAL® Insufflation System (AIS)Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 9±1mmHg |
| AIS at 15±1mmHg | Active comparator | Device: SurgiQuest AIRSEAL® Insufflation System (AIS)Use of the SurgiQuest AIRSEAL® Insufflation System (AIS) at 15±1mmHg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 80 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent laparoscopic/robotic surgery;
Key exclusion criteria (12 listed)
- Advanced refusal of blood transfusion, if necessary;
- Active systemic or cutaneous infection or inflammation;
- Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- Uncontrolled diabetes mellitus
- Known, significant history of bleeding diathesis, coagulopathy, Von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
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 |
|---|---|---|
| SurgiQuest AIRSEAL® Insufflation System (AIS)Also: AISThe SurgiQuest AirSeal Optical Trocar \& Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization. | Device | AIS at 15±1mmHg, AIS at 9±1mmHg |
Primary outcome
Incidence of shoulder pain
Time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of reported shoulder pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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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.
John P Diaz, MD principal investigator
South Miami Hospital, Miami Floridaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgiQuest AIRSEAL® Insufflation System (AIS) in people with Shoulder Pain, run by Cynthia Harris 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 3 inclusion and 12 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 13 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of shoulder pain (time frame: participants will be followed for the duration of hospital stay, an expected average of 24 hours). 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 13 Nov 2019.