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

NCT02837601 | Not Yet Recruiting FDA Device

• 1 other identifier: PRESSURE
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Shoulder Pain

Keywords

Laparoscopic surgical procedures; Shoulder Pain; Abdominal Pain; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain severity and trend

  Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.

• Pressure stability

  During procedure

• Ease of anesthesia management

  During procedure

• Length of recovery room stay

  Post-anesthesia care unit (PACU) discharge, up to 24 hours.

• Length of Stay (LOS)

  Until the time of hospital discharge, up to 10 days.

Study Arms (2)

LOW AIS Pressure AirSeal®

OTHER

AIS with an insufflation pressure target of 9mmHg ±1mmHg

Device: AirSeal® Insufflation System (AIS)

HIGH AIS Pressure AirSeal®

OTHER

AIS with an insufflation pressure target of 15mmHg ±1mm

Device: AirSeal® Insufflation System (AIS)

Interventions

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.

HIGH AIS Pressure AirSeal®; LOW AIS Pressure AirSeal®

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Related Publications (2)

• 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.

  PMID: 19370662 BACKGROUND

• 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.

  PMID: 24503370 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Abdominal Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Todd Ponsky, MD

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle R Jacobs, MA

CONTACT

330-543-4969; mjacobs@akronchildrens.org

Sarah E Pfeiffer, MA

CONTACT

330-543-1327; spfeiffer@akronchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: July 19, 2016
• Study Start: March 1, 2021
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)