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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04520893
Other study ID # 2020-03-010
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 22, 2020
Est. completion date March 2021

Study information

Verified date February 2021
Source Hallym University Kangnam Sacred Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 45
Est. completion date March 2021
Est. primary completion date January 7, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
ventilator setting vcv with pause
ventilator setting vcv with pause
ventilator setting vcv
ventilator setting vcv without pause
ventilator setting pcv-vg
ventilator setting with pcv-vg

Locations

Country Name City State
Korea, Republic of Hallym University Kangnam Sacred Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Eunhee Chun

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary MVCO2 minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software ventilation 15 min later
Secondary 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
Secondary airway compliance Respiratory dynamic compliance (ml/cmH2O; displayed in the ventilator) ventilation 15 min later
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