NCT03571854

Brief Summary

The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery. A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume. This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.

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
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

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

April 19, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2018

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

June 18, 2018

Last Update Submit

July 3, 2018

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Peak airway pressure

    The highest level of pressure applied to the lungs during inhalation

    About 2-3 hours through the surgery

Study Arms (2)

Group PCV-VG

EXPERIMENTAL

Pressure controlled ventilation-volume guaranteed

Device: Group PCV-VG

Group VCV

ACTIVE COMPARATOR

Volume controlled ventilation

Device: Group VCV

Interventions

Group PCV-VGDEVICE

Pressure controlled ventilation-volume guaranteed

Group PCV-VG
Group VCVDEVICE

Volume controlled ventilation

Group VCV

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were scheduled for lumbar spine surgery with the prone position
  • American Society of Anesthesiologists physical status I-III

You may not qualify if:

  • Age under 20 years old or over 70 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 (6)

  • Jo YY, Kim JY, Kwak YL, Kim YB, Kwak HJ. The effect of pressure-controlled ventilation on pulmonary mechanics in the prone position during posterior lumbar spine surgery: a comparison with volume-controlled ventilation. J Neurosurg Anesthesiol. 2012 Jan;24(1):14-8. doi: 10.1097/ANA.0b013e31822c6523.

    PMID: 21897297BACKGROUND

  • 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

  • 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

  • Keszler M. Volume-targeted ventilation. Early Hum Dev. 2006 Dec;82(12):811-8. doi: 10.1016/j.earlhumdev.2006.09.008. Epub 2006 Oct 27.

    PMID: 17069993BACKGROUND

  • Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.

    PMID: 25368784BACKGROUND

  • Lee JM, Lee SK, Kim KM, Kim YJ, Park EY. Comparison of volume-controlled ventilation mode and pressure-controlled ventilation with volume-guaranteed mode in the prone position during lumbar spine surgery. BMC Anesthesiol. 2019 Jul 27;19(1):133. doi: 10.1186/s12871-019-0806-7.

    PMID: 31351445DERIVED

Study Officials

  • Eun Young Park, MD

    Hallym University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Jung Min Lee, MD

CONTACT

+82-31-380-3943vanilla228@hanmail.net

Eun Young Park, MD

CONTACT

+82-31-380-3953parkey00@hallym.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

April 19, 2017

Primary Completion

July 21, 2018

Study Completion

July 28, 2018

Last Updated

July 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)