The Effect of Pressure-controlled Ventilation-volume Guaranteed Mode

NCT ID: NCT03571854

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2018-07-28

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group PCV-VG

Pressure controlled ventilation-volume guaranteed

Group Type EXPERIMENTAL

Group PCV-VG

Intervention Type DEVICE

Pressure controlled ventilation-volume guaranteed

Group VCV

Volume controlled ventilation

Group Type ACTIVE_COMPARATOR

Group VCV

Intervention Type DEVICE

Volume controlled ventilation

Interventions

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Group PCV-VG

Pressure controlled ventilation-volume guaranteed

Intervention Type DEVICE

Group VCV

Volume controlled ventilation

Intervention Type DEVICE

Eligibility Criteria

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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%)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eun Young Park, MD

Role: STUDY_DIRECTOR

Hallym University Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Dongan-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung Min Lee, MD

Role: CONTACT

+82-31-380-3943 ext. 3943

Eun Young Park, MD

Role: CONTACT

+82-31-380-3953 ext. 3953

Facility Contacts

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Eun Young Park, MD

Role: primary

+81-31-380-3953

References

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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.

Reference Type BACKGROUND
PMID: 21897297 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24955188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25232415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17069993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25368784 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31351445 (View on PubMed)

Other Identifiers

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2017-I036

Identifier Type: -

Identifier Source: org_study_id

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