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The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery

NCT ID: NCT01540201

Last Updated: 2013-12-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.

Detailed Description

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Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory pressure are usually applied to improve this disorder including hypoxia, but these methods are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. The application of IRV during OLV has not been performed to our knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we tried to evaluate the effect of IRV during OLV with lung protective strategy.

Conditions

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Lung Cancer One Lung Ventilation Gas Exchange Inverse-ratio Ventilation

Keywords

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one lung ventilation gas exchange inverse-ratio ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1:2 group

conventional I:E ratio group, inspiratory time : expiratory time = 1:1

Group Type ACTIVE_COMPARATOR

Conventional I:E ratio

Intervention Type OTHER

conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model

1:1 group

inspiratory time : expiratory time = 1:1

Group Type EXPERIMENTAL

I:E = 1:1 ratio

Intervention Type OTHER

I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model

Interventions

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Conventional I:E ratio

conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model

Intervention Type OTHER

I:E = 1:1 ratio

I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model

Intervention Type OTHER

Other Intervention Names

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I:E ratio of 1:2 Ventilator : Datex-Ohmeda Aestiva/5 ® model I:E ratio of 1:1 Ventilator : Datex-Ohmeda Aestiva/5 ® model

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective lung lobectomy surgery.
* the duration of one-lung ventilation is more than one hour.
* subjects with more than twenty years old.

Exclusion Criteria

* subjects with past history of pneumothorax, asthma
* Age under 20, more than 70 years.
* Patients with ischemic heart disease, valvular heart disease
* patients with hemodynamic unstability
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sangmin M. Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangmin M. Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Won Ho Kim, MD

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-12-033-002

Identifier Type: -

Identifier Source: org_study_id