Ventilators, MechanicalNCT04520893
Ventilation Strategy for the Elderly Patients in Prone Position
A study testing ventilator setting vcv with pause, ventilator setting vcv and ventilator setting pcv-vg in people with Ventilators, Mechanical, run by Eunhee Chun at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Ventilators, Mechanical
- What is being tested?
- ventilator setting vcv with pause, ventilator setting vcv and ventilator setting pcv-vg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients undergoing elective spine surgery under general anesthesia
Who cannot join
- obesity (body mass index >35 kg/m2)
- chronic obstructive pulmonary disease
- respiratory infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
<Protocol>
- All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.
- 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
- 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
- Ventilators, Mechanical
- Being tested
- ventilator setting vcv with pause, ventilator setting vcv, ventilator setting pcv-vg
- Keywords
- geriatric medicine, protective ventilation, prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilator setting vcv with pauseProcedure or surgery
ventilator setting vcv with pause
ventilator setting vcvProcedure or surgery
ventilator setting vcv without pause
ventilator setting pcv-vgProcedure or surgery
ventilator setting with pcv-vg
| Study group | Role | What they receive |
|---|---|---|
| VCV pause | Experimental | volume controlled ventilation with pause time 30% Receives: Procedure: ventilator setting vcv with pause |
| VCV | Active comparator | volume controlled ventilation (without pause) Receives: Procedure: ventilator setting vcv |
| PCV-VG | Active comparator | pressure controlled ventilation - volume guaranteed Receives: Procedure: ventilator setting pcv-vg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVCO2
minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software
Measured: ventilation 15 min later
Secondary outcomes (2)
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)
Measured: ventilation 15 min later
airway compliance
Respiratory dynamic compliance (ml/cmH2O; displayed in the ventilator)
Measured: ventilation 15 min later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start22 Oct 2020
- Primary completion7 Jan 2021
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilators, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunhee Chun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunhee Chun, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Eunhee Chun, MD.,PhD., Principal investigator, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520893
- Sponsor's protocol ID
- 2020-03-010
- Status last verified
- Feb 2021
- First submitted
- 17 Aug 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Ventilation Strategy for the Elderly Patients During Spine Surgery in Prone Position
- ClinicalTrials.gov ID
- NCT04520893
- Acronym / sponsor ID
- 2020-03-010
- Conditions
- Ventilators, Mechanical
- Keywords
- geriatric medicine, protective ventilation, prone position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eunhee ChunUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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>
- All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.
- 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
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VCV pause | Experimental | Procedure: ventilator setting vcv with pausevolume controlled ventilation with pause time 30% |
| VCV | Active comparator | Procedure: ventilator setting vcvvolume controlled ventilation (without pause) |
| PCV-VG | Active comparator | Procedure: ventilator setting pcv-vgpressure controlled ventilation - volume guaranteed |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective spine surgery under general anesthesia
Key exclusion criteria (3 listed)
- obesity (body mass index >35 kg/m2)
- chronic obstructive pulmonary disease
- respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilator setting vcv with pauseventilator setting vcv with pause | Procedure or surgery | VCV pause |
| ventilator setting vcvventilator setting vcv without pause | Procedure or surgery | VCV |
| ventilator setting pcv-vgventilator setting with pcv-vg | Procedure or surgery | PCV-VG |
Primary outcome
MVCO2
Time frame: ventilation 15 min later
minute CO2 production (ml/min), a parameter of Drager ventilator, displayed in the Primus model and software
2 secondary outcomes
airway pressure
Time frame: ventilation 15 min later
airway compliance
Time frame: ventilation 15 min later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunhee Chun, MD.,PhD. principal investigator
Hallym University Kangnam Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilator setting vcv with pause, ventilator setting vcv and ventilator setting pcv-vg in people with Ventilators, Mechanical, run by Eunhee Chun at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVCO2 (time frame: ventilation 15 min later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021; AzTrials last refreshed its copy on 29 Oct 2026.