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

NCT ID: NCT03887949

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-31

Brief Summary

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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

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1. Total 60 patients with American Society of Anesthesiologists physical status I-II who underwent Robot-assisted hysterectomy were enrolled.
2. 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).
3. 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.
4. 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.
5. 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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VCV

Volume controlled ventilation

Group Type ACTIVE_COMPARATOR

Group VCV

Intervention Type DEVICE

Volume controlled ventilation

PCV

Pressure controlled ventilation

Group Type ACTIVE_COMPARATOR

Group PCV

Intervention Type DEVICE

Pressure controlled ventilation

PCV-VG

Pressure controlled ventilation with volume guarantee

Group Type EXPERIMENTAL

Group PCV-VG

Intervention Type DEVICE

Pressure controlled ventilation with volume guarantee

Interventions

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Group VCV

Volume controlled ventilation

Intervention Type DEVICE

Group PCV

Pressure controlled ventilation

Intervention Type DEVICE

Group PCV-VG

Pressure controlled ventilation with volume guarantee

Intervention Type DEVICE

Eligibility Criteria

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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%)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eun Young Park

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Young Park, MD

Role: STUDY_DIRECTOR

Hallym Univesity Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Dongan-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung Min Lee, MD

Role: CONTACT

+82-31-380-3843 ext. 3943

Eun Young Park, MD

Role: CONTACT

+82-31-380-3953 ext. 3953

Facility Contacts

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Eun Young Park, MD

Role: primary

+81-31-380-3953

References

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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.

Reference Type BACKGROUND
PMID: 27687346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25232415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24955188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20303833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30443174 (View on PubMed)

Other Identifiers

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2017-I013

Identifier Type: -

Identifier Source: org_study_id

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