AirSeal®Insufflation Trocar/CO2 Absorption Study

NCT02654808 | Completed Results FDA Device

• 1 other identifier: AAAQ6474
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare carbon dioxide (CO2) absorption during gynecologic laparoscopy using the AirSeal® valveless trocar system versus standard insufflation trocars at intra-abdominal pressures of 10 and 15 mmHg. The investigators hypothesize that with the AirSeal® valveless trocar system, gynecologic laparoscopy can be performed at a lower intra-abdominal pressure with a possible resultant decrease in CO2 absorption, while maintaining adequate visualization of the operative field for safe completion of surgery.

Conditions

Gynecologic Diseases

Keywords

Gynecology; Laparoscopy; Pneumoperitoneum; CO2 absorption

Outcome Measures

Primary Outcomes (1)

• Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 10 mmHg

  This outcome is measured by calculating the CO2 elimination rate. CO2 absorption rates were obtained at 15 and 60 minutes during each case and an average value was calculated per case. In cases \< 60 minutes, the CO2 absorption rate at 15 minutes will be used.

  15 minutes & 60 minutes from surgery start time

Secondary Outcomes (4)

• Median Surgeon Questionnaire Score When Using AirSeal® Versus Standard Trocars

  At the end of surgery (approximately 1 hour)

• Number of Participants With no Problem When Using AirSeal® Versus Standard Trocars

  At the end of surgery (approximately 1 hour)

• Median VAS Pain Score When Using AirSeal® Versus Standard Trocars

  4 to 6 hours, and 12 to 23 hours following surgery

• Average Carbon Dioxide (CO2) Absorption During Gynecologic Laparoscopy Using the AirSeal® Versus Standard Trocars at Intra-abdominal Pressures of 15 mmHg

  15 minutes & 60 minutes from surgery start time

Study Arms (4)

Standard trocar/ IAP 15 mmHg

ACTIVE COMPARATOR

Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.

Device: Standard trocar

Standard trocar/ IAP 10 mmHg

ACTIVE COMPARATOR

Patients who are randomized into this arm will have their laparoscopic procedures performed with the standard trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.

Device: Standard trocar

AirSeal trocar/ IAP 15 mmHg

ACTIVE COMPARATOR

Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 15 mmHg.

Device: AirSeal trocar

AirSeal trocar/ IAP 10 mmHg

ACTIVE COMPARATOR

Patients who are randomized into this arm will have their laparoscopic procedures performed with the AirSeal trocar insufflator at an intra-abdominal pressure (IAP) of 10 mmHg.

Device: AirSeal trocar

Interventions

AirSeal trocar DEVICE

The AirSeal® trocar is a valveless trocar that has been designed to replace the "trap door" and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes.

AirSeal trocar/ IAP 10 mmHg; AirSeal trocar/ IAP 15 mmHg

Standard trocar DEVICE

A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a "trap door" or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas.

Standard trocar/ IAP 10 mmHg; Standard trocar/ IAP 15 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any woman ≥ 18 years of age undergoing a gynecologic laparoscopic procedure
• Able to understand the consenting process and willing to participate in study

You may not qualify if:

• Patient unable to undergo laparoscopic procedure due to size of pathology or medical comorbidities
• Emergent surgery

Sponsors & Collaborators

• Columbia University: lead
• SurgiQuest, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (16)

• Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.

  PMID: 20888033 BACKGROUND

• Tan PL, Lee TL, Tweed WA. Carbon dioxide absorption and gas exchange during pelvic laparoscopy. Can J Anaesth. 1992 Sep;39(7):677-81. doi: 10.1007/BF03008229.

  PMID: 1394755 BACKGROUND

• Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.

  PMID: 16517337 BACKGROUND

• Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. doi: 10.1016/s0952-8180(01)00286-0.

  PMID: 11498317 BACKGROUND

• CONMED - Transforming Laparosopic Surgery. Available at: http://www.conmed.com/en/hybrid-product-landing-pages/airseal. Retrieved January 12, 2018.

  BACKGROUND

• Wolf JS Jr, Monk TG, McDougall EM, McClennan BL, Clayman RV. The extraperitoneal approach and subcutaneous emphysema are associated with greater absorption of carbon dioxide during laparoscopic renal surgery. J Urol. 1995 Sep;154(3):959-63.

  PMID: 7637101 BACKGROUND

• Ng CS, Gill IS, Sung GT, Whalley DG, Graham R, Schweizer D. Retroperitoneoscopic surgery is not associated with increased carbon dioxide absorption. J Urol. 1999 Oct;162(4):1268-72.

  PMID: 10492177 BACKGROUND

• Motew M, Ivankovich AD, Bieniarz J, Albrecht RF, Zahed B, Scommegna A. Cardiovascular effects and acid-base and blood gas changes during laparoscopy. Am J Obstet Gynecol. 1973 Apr 1;115(7):1002-12. doi: 10.1016/0002-9378(73)90683-2. No abstract available.

  PMID: 4266615 BACKGROUND

• Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni HN, Patel B, Bhavsar MS, Narwaria MB, Thakker R. A prospective randomized, controlled study comparing low pressure versus high pressure pneumoperitoneum during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2009 Jun;19(3):234-40. doi: 10.1097/SLE.0b013e3181a97012.

  PMID: 19542853 BACKGROUND

• Sefr R, Puszkailer K, Jagos F. Randomized trial of different intraabdominal pressures and acid-base balance alterations during laparoscopic cholecystectomy. Surg Endosc. 2003 Jun;17(6):947-50. doi: 10.1007/s00464-002-9046-9. Epub 2003 Mar 14.

  PMID: 12632130 BACKGROUND

• Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.

  PMID: 24686347 BACKGROUND

• Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.

  PMID: 26275545 BACKGROUND

• Park JS, Ahn EJ, Ko DD, Kang H, Shin HY, Baek CH, Jung YH, Woo YC, Kim JY, Koo GH. Effects of pneumoperitoneal pressure and position changes on respiratory mechanics during laparoscopic colectomy. Korean J Anesthesiol. 2012 Nov;63(5):419-24. doi: 10.4097/kjae.2012.63.5.419. Epub 2012 Nov 16.

  PMID: 23198035 BACKGROUND

• Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.

  PMID: 17043939 BACKGROUND

• Kandil TS, El Hefnawy E. Shoulder pain following laparoscopic cholecystectomy: factors affecting the incidence and severity. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):677-82. doi: 10.1089/lap.2010.0112.

  PMID: 20701547 BACKGROUND

• Bogani G, Uccella S, Cromi A, Serati M, Casarin J, Pinelli C, Ghezzi F. Low vs standard pneumoperitoneum pressure during laparoscopic hysterectomy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):466-71. doi: 10.1016/j.jmig.2013.12.091. Epub 2013 Dec 25.

  PMID: 24374246 BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Peritoneal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Timothy Ryntz
• Organization: Columbia University

ter2111@cumc.columbia.edu

212-305-4973

Study Officials

• Timothy Ryntz, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)