NCT04520893

Brief Summary

The investigators compare three ventilation modes; volume controlled ventilation, volume guaranteed pressure controlled ventilation and volume controlled ventilation with pause during spine surgery for the elderly patients. The investigators can reveal that how lung collapse can be reduced by optimizing the inspiratory flow pattern under general anesthesia.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

August 17, 2020

Last Update Submit

February 17, 2021

Conditions

Ventilators, Mechanical

Keywords

geriatric medicine, protective ventilation, prone position

Outcome Measures

Primary Outcomes (1)

  • MVCO2

    minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software

    ventilation 15 min later

Secondary Outcomes (2)

  • airway pressure

    ventilation 15 min later

  • airway compliance

    ventilation 15 min later

Study Arms (3)

VCV pause

EXPERIMENTAL

volume controlled ventilation with pause time 30%

Procedure: ventilator setting vcv with pause

VCV

ACTIVE COMPARATOR

volume controlled ventilation (without pause)

Procedure: ventilator setting vcv

PCV-VG

ACTIVE COMPARATOR

pressure controlled ventilation - volume guaranteed

Procedure: ventilator setting pcv-vg

Interventions

ventilator setting vcv with pausePROCEDURE

ventilator setting vcv with pause

VCV pause
ventilator setting vcvPROCEDURE

ventilator setting vcv without pause

VCV
ventilator setting pcv-vgPROCEDURE

ventilator setting with pcv-vg

PCV-VG

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients undergoing elective spine surgery under general anesthesia

You may not qualify if:

  • obesity (body mass index \>35 kg/m2)
  • chronic obstructive pulmonary disease
  • respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Kangnam Sacred Hospital

Seoul, 07441, South Korea

Location

Study Officials

  • Eunhee Chun, MD.,PhD.

    Hallym University Kangnam Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

October 22, 2020

Primary Completion

January 7, 2021

Study Completion

March 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

KR(1)