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

Primary Purpose

Shoulder Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AirSeal® Insufflation System (AIS)

About this trial

This is an interventional other trial for Shoulder Pain focused on measuring Laparoscopic surgical procedures, Shoulder Pain, Abdominal Pain, Pediatrics

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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

Sites / Locations

Children's Hospital Medical Center of Akron

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

LOW AIS Pressure AirSeal®

HIGH AIS Pressure AirSeal®

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Pressure stability

Stability of intra-abdominal pressure

Ease of anesthesia management

Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.

Length of recovery room stay

A measure of time the patient spends in the post-anesthesia recovery area

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.

Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?

Rate of device-related events

Full Information

NCT ID

NCT02837601

First Posted

January 13, 2015

Last Updated

July 10, 2020

Sponsor

Akron Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02837601

Brief Title

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

Acronym

PRESSURE

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2021 (Anticipated)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Akron Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

Laparoscopic surgical procedures, Shoulder Pain, Abdominal Pain, Pediatrics

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LOW AIS Pressure AirSeal®

Arm Type

Other

Arm Description

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

Arm Title

HIGH AIS Pressure AirSeal®

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

AirSeal® Insufflation System (AIS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post-operative shoulder pain

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain severity and trend

Description

Time Frame

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

Title

Pressure stability

Description

Stability of intra-abdominal pressure

Time Frame

During procedure

Title

Ease of anesthesia management

Description

Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.

Time Frame

During procedure

Title

Length of recovery room stay

Description

A measure of time the patient spends in the post-anesthesia recovery area

Time Frame

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

Title

Length of Stay (LOS)

Description

Time Frame

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

Title

Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?

Time Frame

During hospital stay up to 30 days

Title

Rate of device-related events

Time Frame

During procedure

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michelle R Jacobs, MA

Phone

330-543-4969

mjacobs@akronchildrens.org

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah E Pfeiffer, MA

Phone

330-543-1327

spfeiffer@akronchildrens.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Todd Ponsky, MD

Organizational Affiliation

Akron Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Medical Center of Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle R Jacobs, MA

Phone

330-543-4969

mjacobs@akronchildrens.org

First Name & Middle Initial & Last Name & Degree

Sarah E Pfeiffer, MA

Phone

330-543-1327

spfeiffer@akronchildrens.org

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19370662

Citation

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.

Results Reference

background

PubMed Identifier

24503370

Citation

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.

Results Reference

background

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

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