Ventilation Strategy for the Elderly Patients in Prone Position

Ventilators, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04520893
• Other study ID #: 2020-03-010
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ventilators, Mechanical

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