Health TrialsbyHealthPanel

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

ConditionShoulder Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorAkron Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: LOW AIS Pressure AirSeal®Other 1 intervention
Group B: HIGH AIS Pressure AirSeal®Other 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.
2

Pressure stability

Stability of intra-abdominal pressure

Time frame
During procedure
3

Ease of anesthesia management

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

Time frame
During procedure
4

Length of recovery room stay

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akron Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: