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The Effect of Pressure-controlled Ventilation-volume Guaranteed Mode

Comparison of Pressure-controlled Ventilation-volume Guaranteed Mode With Volume Controlled Ventilation in Prone Position During Lumbar Spine Surgery.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03571854
Enrollment
34
Registered
2018-06-28
Start date
2017-04-19
Completion date
2018-07-28
Last updated
2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief 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. 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

1. Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled. 2. 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). 3. 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. 4. 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. 5. 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.

Interventions

Pressure controlled ventilation-volume guaranteed

DEVICEGroup VCV

Volume controlled ventilation

Sponsors

Hallym University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients who were scheduled for lumbar spine surgery with the prone position * American Society of Anesthesiologists physical status I-III

Exclusion criteria

* 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%)

Design outcomes

Primary

MeasureTime frameDescription
Peak airway pressureAbout 2-3 hours through the surgeryThe highest level of pressure applied to the lungs during inhalation

Countries

South Korea

Contacts

Primary ContactJung Min Lee, MD
vanilla228@hanmail.net+82-31-380-3943
Backup ContactEun Young Park, MD
parkey00@hallym.or.kr+82-31-380-3953

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026