Comparison of Three Modes of Ventilation During Robot-ass... | NCT03887949

Studies
Comparison of Three Modes of Ventilation During Robot-assisted Hysterectomy in Trendelenburg Position

NCT03887949

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

Mar 25, 2019Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Group VCV
Group PCV
Group PCV-VG

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Apr 30, 2019Estimated

Completion Date

May 31, 2019Estimated

First Submitted Date

Mar 21, 2019

First Submission Date that Met QC Criteria

Mar 21, 2019

First Posted Date

Mar 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2019

Last Update Posted Date

Mar 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Young Park, Associate professor, Hallym University Medical CenterPrincipal Investigator

Lead Sponsor

Hallym University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Total 60 patients with American Society of Anesthesiologists physical status I-II who underwent Robot-assisted hysterectomy were enrolled.
All patients were fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with intravenous remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg/kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive VCV (n=20), PCV (n=20), or PCV-VG (n=20) mode. The tidal volume was set to deliver 8 mL/kg of ideal body weight. The respiratory rate(RR) was adjust to maintain end tidal CO2 (ETCO2) 32-37 mmHg.
Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after pneumoperitoneum and Trendelenburg position, (3) 60 minutes after pneumoperitoneum and Trendelenburg position, (4) 15 minutes after pneumoperitoneum withdrawal in supine position.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Group VCV	Device	Volume controlled ventilation	VCV
Group PCV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak airway pressure	The highest level of pressure applied to the lung during inhalation	2-3 hours through the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung Min Lee, MD	Contact	+82-31-380-3843	3943	vanilla228@hanmail.net
Eun Young Park, MD	Contact	+82-31-380-3953	3953	parkey@hallym.or.kr

Overall Officials

Name	Affiliation	Role
Eun Young Park, MD	Hallym Univesity Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital	Recruiting	Anyang-si	Dongan-gu		South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27687346	Background	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.
25232415	Background	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.