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Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure (PRESSURE)

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ClinicalTrials.gov Identifier: NCT02837601
Recruitment Status : Not yet recruiting
First Posted : July 19, 2016
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Todd Ponsky, Akron Children's Hospital

Study Description
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Brief 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. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:

  1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or
  2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.

Condition or disease Intervention/treatment Phase
Shoulder Pain Device: AirSeal® Insufflation System (AIS) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2027
Arms and Interventions
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Arm Intervention/treatment
LOW AIS Pressure AirSeal®
AIS with an insufflation pressure target of 9mmHg ±1mmHg
 Device: 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.
HIGH AIS Pressure AirSeal®
AIS with an insufflation pressure target of 15mmHg ±1mm
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. Pressure stability [ Time Frame: During procedure ]
    Stability of intra-abdominal pressure

  3. Ease of anesthesia management [ Time Frame: During procedure ]
    Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.

  4. Length of recovery room stay [ Time Frame: Post-anesthesia care unit (PACU) discharge, up to 24 hours. ]
    A measure of time the patient spends in the post-anesthesia recovery area

  5. Length of Stay (LOS) [ Time Frame: Until the time of hospital discharge, up to 10 days. ]
    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.

  6. Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs? [ Time Frame: During hospital stay up to 30 days ]
  7. Rate of device-related events [ Time Frame: During procedure ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric subjects (<21 years of age)
  2. > 20 kg in weight;
  3. Capable and willing to provide parental Informed Consent and patient Assent;
  4. Acceptable candidate for laparoscopic surgery;

Exclusion Criteria:

  1. Active cutaneous infection or inflammation;
  2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
  3. Uncontrolled diabetes mellitus
  4. 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);
  5. Severe co-existing morbidities having a life expectancy of less than 30 days;
  6. Currently involved in any other investigational clinical Studies;
  7. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
  8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
  9. Extreme morbid obesity (BMI greater than 45 kg/m2)
  10. Patients presenting with Ascites
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837601


Contacts
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Contact: Michelle R Jacobs, MA 330-543-4969 mjacobs@akronchildrens.org
Contact: Sarah E Pfeiffer, MA 330-543-1327 spfeiffer@akronchildrens.org

Locations
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United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Contact: Michelle R Jacobs, MA    330-543-4969    mjacobs@akronchildrens.org   
Contact: Sarah E Pfeiffer, MA    330-543-1327    spfeiffer@akronchildrens.org   
Sponsors and Collaborators
Akron Children's Hospital
Investigators
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Principal Investigator: Todd Ponsky, MD Akron Children's Hospital
More Information
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Publications:

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Responsible Party: Todd Ponsky, MD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT02837601    
Other Study ID Numbers: PRESSURE
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Todd Ponsky, Akron Children's Hospital:
Laparoscopic surgical procedures
Shoulder Pain
Abdominal Pain
Pediatrics
Additional relevant MeSH terms:
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Shoulder Pain
Pneumoperitoneum
Arthralgia
Joint Diseases
Musculoskeletal Diseases
 Pain
Neurologic Manifestations
Peritoneal Diseases
Digestive System Diseases