Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™

NCT ID: NCT03390127

Last Updated: 2018-04-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2018-03-21

Brief Summary

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The purpose of the present study is to compare the effect of PEEP on arterial oxygen partial pressure in elderly patients undergoing urologic surgery using LMA supreme™ in a lithotomy position.

Detailed Description

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Positive end-expiratory pressure (PEEP) during general anesthesia with mechanical ventilation is routinely used as a standard lung protective strategy to prevent postoperative pulmonary complications including atelectasis.

In urologic surgery, elderly patients are common. Since aging decreases the elasticity of lung tissues and allowing the collapse of small airways, old age is a risk factor for postoperative atelectasis. Lithotomy position is the preferred position in urologic surgery. However, it causes the abdominal viscera to displace the diaphragm cephalad, reducing lung compliance and resulting atelectasis. Therefore, in elderly patients undergoing urologic surgery with lithotomy position, PEEP may be essential to prevent postoperative atelectasis.

Laryngeal mask airway (LMA) has been widely used in urologic surgery with lithotomy position because of short surgical time and no necessity of administration of muscle relaxant. However, application of PEEP when using LMA is still controversy. Therefore, in the present study, we aimed to compare the effect of PEEP on arterial oxygen partial pressure in elderly patients undergoing urologic surgery using LMA supreme™ in a lithotomy position.

Conditions

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Urinary Bladder Neoplasms Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group P

After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation.

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.

Group Z

After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PEEP

After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.

Intervention Type OTHER

Other Intervention Names

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Application of PEEP 7 cmH2O

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing urologic surgery with lithotomy position under general anesthesia
* Elderly patients (65 ≤ Age \< 80)
* American Society of Anesthesiologists (ASA) physical status: 1-3
* Patients who voluntarily agreed to participate in this clinical study

Exclusion Criteria

* Heart failure (ejection fraction ≤ 40%)
* Hemodynamic instability during perioperative period
* Lung diseases (chronic obstructive pulmonary disease, asthma, bullae, pleural effusion)
* Obesity (BMI ≥ 30 kg/m2)
* Neck or upper respiratory tract pathologies
* An increased risk of pulmonary aspiration
* Anticipation of the difficult laryngeal mask fixation due to poor dentition
Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-1397

Identifier Type: -

Identifier Source: org_study_id

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