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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство AirSeal® Insufflation System (AIS)
  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 ut

Первичные конечные точки

• Post-operative shoulder pain [Срок оценки: Post-operative shoulder pain will be assessed at 24 hours after surgery, or at the time of discharge, whichever comes first.]

Вторичные конечные точки (7)

• Pain severity and trend [Срок оценки: Pain will be assessed at least daily from the immediate post-operative period until discharge from the hospital, up to 10 days.]
• Pressure stability [Срок оценки: During procedure]
• Ease of anesthesia management [Срок оценки: During procedure]
• Length of recovery room stay [Срок оценки: Post-anesthesia care unit (PACU) discharge, up to 24 hours.]
• Length of Stay (LOS) [Срок оценки: Until the time of hospital discharge, up to 10 days.]
• Procedural related Adverse Events/ Serious Adverse Events (AEs/ SAEs? [Срок оценки: During hospital stay up to 30 days]
• Rate of device-related events [Срок оценки: During procedure]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Children's Hospital Medical Center of Akron — Akron

Публикации

• 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
• 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

Идентификаторы

NCT: NCT02837601 · PRESSURE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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