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)
Sponsored by
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
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
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
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
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.
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
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.
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
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.
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
No
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
Email
mjacobs@akronchildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Pfeiffer, MA
Phone
330-543-1327
Email
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
Email
mjacobs@akronchildrens.org
First Name & Middle Initial & Last Name & Degree
Sarah E Pfeiffer, MA
Phone
330-543-1327
Email
spfeiffer@akronchildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
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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