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

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:

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

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Device: AirSeal® Insufflation System (AIS)

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 Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle R Jacobs, MA; Phone Number: 330-543-4969; Email: mjacobs@akronchildrens.org
• Study Contact Backup: Name: Sarah E Pfeiffer, MA; Phone Number: 330-543-1327; Email: spfeiffer@akronchildrens.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Children's Hospital Medical Center of Akron
      • Contact: Michelle R Jacobs, MA; Phone Number: 330-543-4969; Email: mjacobs@akronchildrens.org
      • Contact: Sarah E Pfeiffer, MA; Phone Number: 330-543-1327; Email: spfeiffer@akronchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	During procedure
Ease of anesthesia management	Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.	During procedure
Length of recovery room stay	A measure of time the patient spends in the post-anesthesia recovery area	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.	Until the time of hospital discharge, up to 10 days.
Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?		During hospital stay up to 30 days
Rate of device-related events		During procedure

Collaborators and Investigators

• Sponsor: Akron Children's Hospital
• Investigators: Principal Investigator: Todd Ponsky, MD, Akron Children's Hospital

Publications and helpful links

General Publications

• Hua 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Abdominal Pain; Shoulder Pain; Pediatrics; Laparoscopic surgical procedures
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pneumoperitoneum; Shoulder Pain
• Other Study ID Numbers: PRESSURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes