Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-11 @ 7:36 AM
Study NCT ID:
NCT04520893
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2020-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation Strategy for the Elderly Patients in Prone Position
Sponsor:
Eunhee Chun
Organization:
Study Overview
Official Title:
Modification of Ventilation Strategy for the Elderly Patients During Spine Surgery in Prone Position
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
\<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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: