AnesthesiaNCT03571854
The Effect of Pressure-controlled Ventilation-volume Guaranteed Mode
A study testing Group PCV-VG and Group VCV in people with Anesthesia, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery. A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Group PCV-VG and Group VCV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2017to 28 Jul 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for lumbar spine surgery with the prone position
- American Society of Anesthesiologists physical status I-III
Who cannot join
- Age under 20 years old or over 70 years old
- Body mass index > 30 kg/m2
- Systolic blood pressure < 100 mmHg
- Heart rate < 60 bpm
- Uncompensated cardiac disease
- FEV1 < 60%
- Hypoxemia (PaO2 < 60 mmHg or oxygen saturation < 90%)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Dongan-gu
Eun Young Park, MD, +81-31-380-3953, parkey00@hallym.or.kr
About this study
Official title: Comparison of Pressure-controlled Ventilation-volume Guaranteed Mode With Volume Controlled Ventilation in Prone Position During Lumbar Spine Surgery.
The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery.
A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume.
This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.
Read the detailed description
- Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled.
- All patients fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg.kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
- A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
- All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive either PCV-VG (n=17) or VCV (n=17) mode. The tidal volume in both group were set to deliver 8 mL/kg of ideal body weight. The respiratory rate (RR) was adjust to maintain end tidal CO2 (ETCO2) 33-38 mmHg.
- Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after turning the patient to the prone position, (3) 60 minutes after turning the patient to the prone position, (4) 15 minutes after turning the patient to supine position at the end of surgery.
- Conditions
- Anesthesia
- Being tested
- Group PCV-VG, Group VCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PCV-VGDevice
Pressure controlled ventilation-volume guaranteed
Group VCVDevice
Volume controlled ventilation
| Study group | Role | What they receive |
|---|---|---|
| Group PCV-VG | Experimental | Pressure controlled ventilation-volume guaranteed Receives: Device: Group PCV-VG |
| Group VCV | Active comparator | Volume controlled ventilation Receives: Device: Group VCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
The highest level of pressure applied to the lungs during inhalation
Measured: About 2-3 hours through the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start19 Apr 2017
- Primary completion21 Jul 2018 (estimated)
- Study completion28 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun Young Park, MD, Study director, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571854
- Sponsor's protocol ID
- 2017-I036
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jo YY, Kim JY, Kwak YL, Kim YB, Kwak HJ. The effect of pressure-controlled ventilation on pulmonary mechanics in the prone position during posterior lumbar spine surgery: a comparison with volume-controlled ventilation. J Neurosurg Anesthesiol. 2012 Jan;24(1):14-8. doi: 10.1097/ANA.0b013e31822c6523.
PubMed 21897297Pu J, Liu Z, Yang L, Wang Y, Jiang J. Applications of pressure control ventilation volume guaranteed during one-lung ventilation in thoracic surgery. Int J Clin Exp Med. 2014 Apr 15;7(4):1094-8. eCollection 2014.
PubMed 24955188Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 2014 Aug 15;7(8):2242-7. eCollection 2014.
PubMed 25232415Keszler M. Volume-targeted ventilation. Early Hum Dev. 2006 Dec;82(12):811-8. doi: 10.1016/j.earlhumdev.2006.09.008. Epub 2006 Oct 27.
PubMed 17069993Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.
PubMed 25368784Lee JM, Lee SK, Kim KM, Kim YJ, Park EY. Comparison of volume-controlled ventilation mode and pressure-controlled ventilation with volume-guaranteed mode in the prone position during lumbar spine surgery. BMC Anesthesiol. 2019 Jul 27;19(1):133. doi: 10.1186/s12871-019-0806-7.
PubMed 31351445
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pressure-controlled Ventilation-volume Guaranteed Mode With Volume Controlled Ventilation in Prone Position During Lumbar Spine Surgery.
- ClinicalTrials.gov ID
- NCT03571854
- Acronym / sponsor ID
- 2017-I036
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 21 Jul 2018 (estimated)
- Study completion
- 28 Jul 2018 (estimated)
- First posted
- 28 Jun 2018 (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 anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery.
A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume.
This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.
Detailed description
- Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled.
- All patients fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg.kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
- A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
- All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive either PCV-VG (n=17) or VCV (n=17) mode. The tidal volume in both group were set to deliver 8 mL/kg of ideal body weight. The respiratory rate (RR) was adjust to maintain end tidal CO2 (ETCO2) 33-38 mmHg.
- Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after turning the patient to the prone position, (3) 60 minutes after turning the patient to the prone position, (4) 15 minutes after turning the patient to supine position at the end of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PCV-VG | Experimental | Device: Group PCV-VGPressure controlled ventilation-volume guaranteed |
| Group VCV | Active comparator | Device: Group VCVVolume controlled ventilation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were scheduled for lumbar spine surgery with the prone position
- American Society of Anesthesiologists physical status I-III
Key exclusion criteria (7 listed)
- Age under 20 years old or over 70 years old
- Body mass index > 30 kg/m2
- Systolic blood pressure < 100 mmHg
- Heart rate < 60 bpm
- Uncompensated cardiac disease
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 |
|---|---|---|
| Group PCV-VGPressure controlled ventilation-volume guaranteed | Device | Group PCV-VG |
| Group VCVVolume controlled ventilation | Device | Group VCV |
Primary outcome
Peak airway pressure
Time frame: About 2-3 hours through the surgery
The highest level of pressure applied to the lungs during inhalation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 21897297Jo YY, Kim JY, Kwak YL, Kim YB, Kwak HJ. The effect of pressure-controlled ventilation on pulmonary mechanics in the prone position during posterior lumbar spine surgery: a comparison with volume-controlled ventilation. J Neurosurg Anesthesiol. 2012 Jan;24(1):14-8. doi: 10.1097/ANA.0b013e31822c6523.
- Background: PubMed 24955188Pu J, Liu Z, Yang L, Wang Y, Jiang J. Applications of pressure control ventilation volume guaranteed during one-lung ventilation in thoracic surgery. Int J Clin Exp Med. 2014 Apr 15;7(4):1094-8. eCollection 2014.
- Background: PubMed 25232415Dion JM, McKee C, Tobias JD, Sohner P, Herz D, Teich S, Rice J, Barry ND, Michalsky M. Ventilation during laparoscopic-assisted bariatric surgery: volume-controlled, pressure-controlled or volume-guaranteed pressure-regulated modes. Int J Clin Exp Med. 2014 Aug 15;7(8):2242-7. eCollection 2014.
- Background: PubMed 17069993Keszler M. Volume-targeted ventilation. Early Hum Dev. 2006 Dec;82(12):811-8. doi: 10.1016/j.earlhumdev.2006.09.008. Epub 2006 Oct 27.
- Background: PubMed 25368784Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.
- Derived from this study: PubMed 31351445Lee JM, Lee SK, Kim KM, Kim YJ, Park EY. Comparison of volume-controlled ventilation mode and pressure-controlled ventilation with volume-guaranteed mode in the prone position during lumbar spine surgery. BMC Anesthesiol. 2019 Jul 27;19(1):133. doi: 10.1186/s12871-019-0806-7.
- Individual participant dataSharing planned: No
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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.
Eun Young Park, MD study director
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group PCV-VG and Group VCV in people with Anesthesia, run by Hallym University Medical Center 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 2 inclusion and 7 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 6 Jul 2018. 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?
Contact Jung Min Lee, MD (+82-31-380-3943 ext. 3943, vanilla228@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak airway pressure (time frame: About 2-3 hours through the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03571854, which also lists 6 linked publications.
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 6 Jul 2018.