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

Not Applicable

Not yet recruiting

• Conditions: Shoulder Pain
• Interventions: Device: AirSeal® Insufflation System (AIS)

• Registration Number: NCT02837601
• Lead Sponsor: Akron Children's Hospital

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.

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 Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13
• Study Start: 2021-03
• Primary Completion: 2025-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIGH AIS Pressure AirSeal®	AirSeal® Insufflation System (AIS)	AIS with an insufflation pressure target of 15mmHg ±1mm
LOW AIS Pressure AirSeal®	AirSeal® Insufflation System (AIS)	AIS with an insufflation pressure target of 9mmHg ±1mmHg

Primary Outcome Measures

Name	Time	Method
Post-operative shoulder pain	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

Name	Time	Method
Ease of anesthesia management	During procedure	Excessively high peak and/or mean airway pressures. Anesthesiologist reported difficulty with ventilation.
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.	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.
Rate of device-related events	During procedure
Length of Stay (LOS)	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.
Pressure stability	During procedure	Stability of intra-abdominal pressure
Length of recovery room stay	Post-anesthesia care unit (PACU) discharge, up to 24 hours.	A measure of time the patient spends in the post-anesthesia recovery area
Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs?	During hospital stay up to 30 days

Trial Locations

Locations (1)

Children's Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States