NCT03887949

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

March 21, 2019

Last Update Submit

March 21, 2019

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Peak airway pressure

    The highest level of pressure applied to the lung during inhalation

    2-3 hours through the surgery

Study Arms (3)

VCV

ACTIVE COMPARATOR

Volume controlled ventilation

Device: Group VCV

PCV

ACTIVE COMPARATOR

Pressure controlled ventilation

Device: Group PCV

PCV-VG

EXPERIMENTAL

Pressure controlled ventilation with volume guarantee

Device: Group PCV-VG

Interventions

Group VCVDEVICE

Volume controlled ventilation

VCV
Group PCVDEVICE

Pressure controlled ventilation

PCV
Group PCV-VGDEVICE

Pressure controlled ventilation with volume guarantee

PCV-VG

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were scheduled for Robot-assisted hysterectomy
  • American Society of Anesthesiologists physical status I-II

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Dongan-gu, South Korea

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27687346BACKGROUND

  • 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.

    PMID: 25232415BACKGROUND

  • 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.

    PMID: 24955188BACKGROUND

  • Ogurlu M, Kucuk 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.

    PMID: 20303833BACKGROUND

  • 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.

    PMID: 30443174BACKGROUND

Study Officials

  • Eun Young Park, MD

    Hallym Univesity Medical Center

    STUDY DIRECTOR

Central Study Contacts

Jung Min Lee, MD

CONTACT

+82-31-380-3843vanilla228@hanmail.net

Eun Young Park, MD

CONTACT

+82-31-380-3953parkey@hallym.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 21, 2019

First Posted

March 25, 2019

Study Start

May 1, 2018

Primary Completion

April 30, 2019

Study Completion

May 31, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

KR(1)