Anesthesia Clinical Trial
Official title:
Comparison of Three Modes of Ventilation During Robot-assisted Hysterectomy in Trendelenburg Position: Volume Controlled Ventilation, Pressure Controlled Ventilation, and Pressure Controlled Ventilation With Volume Guarantee.
NCT number | NCT03887949 |
Other study ID # | 2017-I013 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | May 31, 2019 |
Robot-assisted hysterectomy is associated with pneumoperioneum with CO2 and Trendelenburg position, which may have adverse cardiopulmonary effects. A new ventilation mode; pressure-controlled ventilation with volume guaranteed mode (PCV-VG) delivers constant tidal volume with constant inspiratory pressure, using a decelerating flow pattern. This prospective, randomized study is designed to compare the effects of PCV-VG, volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) on respiratory and hemodynamic variables in patients undergoing Robot-assisted hysterectomy.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who were scheduled for Robot-assisted hysterectomy - American Society of Anesthesiologists physical status I-II Exclusion Criteria: - Age under 20 years old or over 65 years old - Body mass index > 30 kg/m2 - Systolic blood pressure < 100 mmHg - Heart rate < 60 bpm - Uncompensated cardiac disease - FEV1 < 60% - Hypoxemia (PaO2 < 60 mmHg or oxygen saturation < 90%) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | Dongan-gu |
Lead Sponsor | Collaborator |
---|---|
Hallym University Medical Center |
Korea, Republic of,
Assad OM, El Sayed AA, Khalil MA. Comparison of volume-controlled ventilation and pressure-controlled ventilation volume guaranteed during laparoscopic surgery in Trendelenburg position. J Clin Anesth. 2016 Nov;34:55-61. doi: 10.1016/j.jclinane.2016.03.053. Epub 2016 May 2. — View Citation
Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 2014 Aug 15;7(8):2242-7. eCollection 2014. — View Citation
Kim MS, Soh S, Kim SY, Song MS, Park JH. Comparisons of Pressure-controlled Ventilation with Volume Guarantee and Volume-controlled 1:1 Equal Ratio Ventilation on Oxygenation and Respiratory Mechanics during Robot-assisted Laparoscopic Radical Prostatectomy: a Randomized-controlled Trial. Int J Med Sci. 2018 Oct 20;15(13):1522-1529. doi: 10.7150/ijms.28442. eCollection 2018. — View Citation
Ogurlu M, Küçük M, Bilgin F, Sizlan A, Yanarates O, Eksert S, Karasahin E, Cosar A. Pressure-controlled vs volume-controlled ventilation during laparoscopic gynecologic surgery. J Minim Invasive Gynecol. 2010 May-Jun;17(3):295-300. doi: 10.1016/j.jmig.2009.10.007. Epub 2010 Mar 19. — View Citation
Pu J, Liu Z, Yang L, Wang Y, Jiang J. Applications of pressure control ventilation volume guaranteed during one-lung ventilation in thoracic surgery. Int J Clin Exp Med. 2014 Apr 15;7(4):1094-8. eCollection 2014. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak airway pressure | The highest level of pressure applied to the lung during inhalation | 2-3 hours through the surgery |
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