Shoulder PainPRESSURENCT02837601
Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure
A study testing AirSeal® Insufflation System (AIS) in people with Shoulder Pain, run by Akron Children's Hospital at 1 site in United States.
Trial summary
A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- AirSeal® Insufflation System (AIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric subjects (<21 years of age)
- > 20 kg in weight;
- Capable and willing to provide parental Informed Consent and patient Assent;
- Acceptable candidate for laparoscopic surgery;
Who cannot join
- Active 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(international normalized ratio) ≥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;
- Currently involved in any other investigational clinical Studies;
Show all 10Show fewer
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- 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)
- Patients presenting with Ascites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Michelle R Jacobs, MA, 330-543-4969, mjacobs@akronchildrens.org
Sarah E Pfeiffer, MA, 330-543-1327, spfeiffer@akronchildrens.org
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
A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:
- AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
- AIS with an insufflation pressure target of 15mmHg ±1mmHg.
Read the detailed description
The study is designed and powered to demonstrate superiority of the AIS at low pressure vs. at higher pressure on a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9mmHg ±1mmHg or to AIS with an insufflation target pressure of 15mmHg ±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, 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 surgery.
- Conditions
- Shoulder Pain
- Being tested
- AirSeal® Insufflation System (AIS)
- Keywords
- Laparoscopic surgical procedures, Shoulder Pain, Abdominal Pain, Pediatrics
- Medical subject headings
- Shoulder Pain, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSeal® Insufflation System (AIS)Device
The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.
| Study group | Role | What they receive |
|---|---|---|
| LOW AIS Pressure AirSeal® | Other | AIS with an insufflation pressure target of 9mmHg ±1mmHg Receives: Device: AirSeal® Insufflation System (AIS) |
| HIGH AIS Pressure AirSeal® | Other | AIS with an insufflation pressure target of 15mmHg ±1mm Receives: Device: AirSeal® Insufflation System (AIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative shoulder pain
Severity of shoulder pain, which will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
Measured: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.
Secondary outcomes (7)
Pain severity and trend
Severity of shoulder pain, back pain, abdominal pain. Pain will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
Measured: Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.
Pressure stability
Stability of intra-abdominal pressure
Measured: During procedure
Ease of anesthesia management
Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.
Measured: During procedure
Length of recovery room stay
A measure of time the patient spends in the post-anesthesia recovery area
Measured: Post-anesthesia care unit (PACU) discharge, up to 24 hours.
Length of Stay (LOS)
The length of hospital stay associated with the surgery. This will be assessed through study completion. It is anticipated to be less than 10 days but could potentially exceed this length as the length of stay cannot always be predicted and there is no upper limit on hospital length of stay.
Measured: Until the time of hospital discharge, up to 10 days.
Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?
Measured: During hospital stay up to 30 days
Rate of device-related events
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startMar 2021 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Ponsky, Akron Children's Hospital
- Investigators
- Todd Ponsky, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837601
- Sponsor's protocol ID
- PRESSURE
- Acronym
- PRESSURE
- Status last verified
- Jul 2020
- First submitted
- 13 Jan 2015
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gurusamy KS, Samraj K, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006930. doi: 10.1002/14651858.CD006930.pub2.
PubMed 19370662Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
PubMed 24503370
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. 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
- NCT02837601
- Acronym / sponsor ID
- PRESSURE / PRESSURE
- Conditions
- Shoulder Pain
- Keywords
- Laparoscopic surgical procedures, Shoulder Pain, Abdominal Pain, Pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Jul 2016 (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.
A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:
- AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
- AIS with an insufflation pressure target of 15mmHg ±1mmHg.
Detailed description
The study is designed and powered to demonstrate superiority of the AIS at low pressure vs. at higher pressure on a single key effectiveness measure: Incidence of shoulder pain. Patients will be randomized 1:1 to either AIS with an insufflation pressure target of 9mmHg ±1mmHg or to AIS with an insufflation target pressure of 15mmHg ±1mmHg.
Secondary outcome measures include severity of shoulder pain measured using a VAS scale and medication use, 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 surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOW AIS Pressure AirSeal® | Other | Device: AirSeal® Insufflation System (AIS)AIS with an insufflation pressure target of 9mmHg ±1mmHg |
| HIGH AIS Pressure AirSeal® | Other | Device: AirSeal® Insufflation System (AIS)AIS with an insufflation pressure target of 15mmHg ±1mm |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric subjects (<21 years of age)
- > 20 kg in weight;
- Capable and willing to provide parental Informed Consent and patient Assent;
- Acceptable candidate for laparoscopic surgery;
Key exclusion criteria (10 listed)
- Active 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(international normalized ratio) ≥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;
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® Insufflation System (AIS)The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier. | Device | HIGH AIS Pressure AirSeal®, LOW AIS Pressure AirSeal® |
Primary outcome
Post-operative shoulder pain
Time frame: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.
Severity of shoulder pain, which will be measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale or Wong-Baker FACES Pain Rating Scale, whichever is deemed more appropriate by the clinician assessing the patient.
7 secondary outcomes
Pain severity and trend
Time frame: Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.
Pressure stability
Time frame: During procedure
Ease of anesthesia management
Time frame: During procedure
Length of recovery room stay
Time frame: Post-anesthesia care unit (PACU) discharge, up to 24 hours.
Length of Stay (LOS)
Time frame: Until the time of hospital discharge, up to 10 days.
Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?
Time frame: During hospital stay up to 30 days
Rate of device-related events
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 19370662Gurusamy KS, Samraj K, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006930. doi: 10.1002/14651858.CD006930.pub2.
- Background: PubMed 24503370Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Todd Ponsky, MD principal investigator
Akron Children's Hospital
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® Insufflation System (AIS) in people with Shoulder Pain, run by Akron Children's Hospital 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Jul 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle R Jacobs, MA (330-543-4969, mjacobs@akronchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative shoulder pain (time frame: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.). 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 NCT02837601, which also lists 2 linked publications.
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 Jul 2020.