Ventilation Strategy for the Elderly Patients in Prone Po... | NCT04520893

Studies
Ventilation Strategy for the Elderly Patients in Prone Position

NCT04520893

Sponsor

Eunhee Chun

Status

Unknown status

Last Update Posted

Feb 18, 2021Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Ventilators, Mechanical

Interventions

ventilator setting vcv with pause
ventilator setting vcv
ventilator setting 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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2020Actual

Primary Completion Date

Jan 7, 2021Actual

Completion Date

Mar 2021Estimated

First Submitted Date

Aug 17, 2020

First Submission Date that Met QC Criteria

Aug 19, 2020

First Posted Date

Aug 20, 2020Actual

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

Feb 17, 2021

Last Update Posted Date

Feb 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eunhee Chun, Assistant professor, Hallym University Kangnam Sacred Heart HospitalSponsor-Investigator

Lead Sponsor

Eunhee ChunOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

Detailed Description

All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.
Ventilation strategy:
- Pressure controlled ventilation volume guaranteed (PCV-VG) mode or volume control ventilation (VCV) mode
- tidal volume 6-8 mL/kg (predicted body weight)
- Inspiratory/expiratory (I/E) ratio 1:1.5
- Inspired oxygen concentration (FIO2) 0.5 with air
- 3.0 L/min of inspiratory fresh gas flow
- Positive end-expiratory pressure (PEEP) of 5 cm H2O
- Respiratory rate (RR) of 10 to 14 min-1
After prone positioning and hemodynamic condition was stabilized, patients were ventilated with VCV, PCV-VG mode, VCV with pause following a randomized order, previously determined for each patient. Before each ventilator setting was started, lung recruitment maneuvers were performed to set the lungs to a defined baseline status.
- ventilation order : one of the following examples is taken by randomization.

VCV 15 min -- VCV pause 15min -- PCV-VG 15min

VCV 15 min -- PCV-VG 15min -- VCV pause 15min

VCV pause 15min -- VCV 15 min -- PCV-VG 15min

VCV pause 15min -- PCV-VG 15min -- VCV 15 min

PCV-VG 15min -- VCV 15 min -- VCV pause 15min

PCV-VG 15min -- VCV pause 15min -- VCV 15 min

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

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ventilator setting vcv with pause	Procedure	ventilator setting vcv with pause	VCV pause

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MVCO2	minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software	ventilation 15 min later

Secondary Outcomes

Measure	Description	Time Frame
airway pressure	peak airway pressure (cmH2O; displayed in the ventilator), plateau pressure (cmH2O; diaplayed in the ventilator), driving pressure(cmH2O, plateau pressure minus peak airway pressure)	ventilation 15 min later
airway compliance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing elective spine surgery under general anesthesia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eunhee Chun, MD.,PhD.	Hallym University Kangnam Sacred Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Kangnam Sacred Hospital		Seoul		07441	South Korea