Ventilation Strategy for the Elderly Patients in Prone Position

NCT ID: NCT04520893

Last Updated: 2021-02-18

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-03-31

Brief Summary

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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

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\<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

Conditions

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Ventilators, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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VCV pause

volume controlled ventilation with pause time 30%

Group Type EXPERIMENTAL

ventilator setting vcv with pause

Intervention Type PROCEDURE

ventilator setting vcv with pause

VCV

volume controlled ventilation (without pause)

Group Type ACTIVE_COMPARATOR

ventilator setting vcv

Intervention Type PROCEDURE

ventilator setting vcv without pause

PCV-VG

pressure controlled ventilation - volume guaranteed

Group Type ACTIVE_COMPARATOR

ventilator setting pcv-vg

Intervention Type PROCEDURE

ventilator setting with pcv-vg

Interventions

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ventilator setting vcv with pause

ventilator setting vcv with pause

Intervention Type PROCEDURE

ventilator setting vcv

ventilator setting vcv without pause

Intervention Type PROCEDURE

ventilator setting pcv-vg

ventilator setting with pcv-vg

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunhee Chun

OTHER

Sponsor Role lead

Responsible Party

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Eunhee Chun

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eunhee Chun, MD.,PhD.

Role: PRINCIPAL_INVESTIGATOR

Hallym University Kangnam Sacred Heart Hospital

Locations

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Hallym University Kangnam Sacred Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-03-010

Identifier Type: -

Identifier Source: org_study_id

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