Ventilation Strategy for the Elderly Patients in Prone Position

February 17, 2021 updated by: Eunhee Chun

Modification of Ventilation Strategy for the Elderly Patients During Spine Surgery in Prone Position

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

<Protocol>

  1. All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.

  2. 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

  3. 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

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VCV pause
volume controlled ventilation with pause time 30%
Procedure: ventilator setting vcv with pause
ventilator setting vcv with pause
Active Comparator: VCV
volume controlled ventilation (without pause)
Procedure: ventilator setting vcv
ventilator setting vcv without pause
Active Comparator: PCV-VG
pressure controlled ventilation - volume guaranteed
Procedure: ventilator setting pcv-vg
ventilator setting with pcv-vg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
airway pressure
Time Frame: ventilation 15 min later
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
Time Frame: ventilation 15 min later
Respiratory dynamic compliance (ml/cmH2O; displayed in the ventilator)
ventilation 15 min later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunhee Chun

Investigators

  • Principal Investigator: Eunhee Chun, MD.,PhD., Hallym University Kangnam Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2020

Primary Completion (Actual)

January 7, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-03-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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