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.

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Device: Group VCV; Device: Group PCV-VG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Min Lee, MD; Phone Number: 3943 +82-31-380-3943; Email: vanilla228@hanmail.net
• Study Contact Backup: Name: Eun Young Park, MD; Phone Number: 3953 +82-31-380-3953; Email: parkey00@hallym.or.kr

Study Locations

• Korea, Republic of
  • Dongan-gu
    • Anyang-si, Dongan-gu, Korea, Republic of
      • Recruiting
      • Hallym University Sacred Heart Hospital
      • Contact: Eun Young Park, MD; Phone Number: +81-31-380-3953; Email: parkey00@hallym.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group PCV-VG; Pressure controlled ventilation-volume guaranteed	Device: Group PCV-VG; Pressure controlled ventilation-volume guaranteed
Active Comparator: Group VCV; Volume controlled ventilation	Device: Group VCV; Volume controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak airway pressure	The highest level of pressure applied to the lungs during inhalation	About 2-3 hours through the surgery

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Study Director: Eun Young Park, MD, Hallym University Medical Center

Publications and helpful links

General Publications

• Song 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.
• Dion 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.
• Pu 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.
• 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.
• Keszler 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.
• Lee 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Anticipated): July 21, 2018
• Study Completion (Anticipated): July 28, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2017-I036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No