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The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

NCT ID: NCT01379313

Last Updated: 2012-10-01

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-03-31

Brief Summary

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In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

Detailed Description

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In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

Conditions

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Uterine Myoma Ovarian Cyst Laparoscopic Gynecologic Surgery

Keywords

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laparoscopic gynecologic surgery gas exchange inspiratory time expiratory time I:E ratio

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

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 PROCEDURE

conventional I:E ratio of 1:2 is applied.

1:1 group

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

Group Type EXPERIMENTAL

1:1 ratio

Intervention Type PROCEDURE

I:E ratio of 1:1 is applied.

2:1 group

inverse ratio group, inspiratory time : expiratory time = 2:1

Group Type EXPERIMENTAL

2:1 group

Intervention Type PROCEDURE

Inverse I:E ratio of 2:1 is applied.

1:2 PEEP group

I:E ratio of 1:2 with external PEEP of 5 cm H2O

Group Type ACTIVE_COMPARATOR

conventional I:E ratio

Intervention Type PROCEDURE

conventional I:E ratio of 1:2 is applied.

external PEEP

Intervention Type PROCEDURE

external positive end-expiratory pressure of 5 cmH2O is applied.

Interventions

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conventional I:E ratio

conventional I:E ratio of 1:2 is applied.

Intervention Type PROCEDURE

1:1 ratio

I:E ratio of 1:1 is applied.

Intervention Type PROCEDURE

2:1 group

Inverse I:E ratio of 2:1 is applied.

Intervention Type PROCEDURE

external PEEP

external positive end-expiratory pressure of 5 cmH2O is applied.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective gynecologic laparoscopic surgery
* the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes

Exclusion Criteria

* ASA (American society of anesthesiologists) classification of the subjects more than III.
* Age under 20, or more than 65 years.
* Past history of pneumothorax, COPD, asthma.
* Patients with ischemic heart disease, valvular heart disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 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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Tae Soo Hahm

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Soo Hahm, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Samsung Medical Center

Won Ho Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Seoul Hospital, Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-04-007

Identifier Type: -

Identifier Source: org_study_id