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Clinical Trials/NCT03390127
NCT03390127
Completed
Not Applicable

Effect of Positive End-expiratory Pressure on Arterial Oxygen Partial Pressure in Elderly Patients Undergoing Urologic Surgery Using LMA Supreme™ in Lithotomy Position

Asan Medical Center1 site in 1 country68 target enrollmentJanuary 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Bladder Neoplasms
Sponsor
Asan Medical Center
Enrollment
68
Locations
1
Primary Endpoint
The difference of arterial oxygen partial pressure (PaO2) between group P and group Z
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2018
End Date
March 21, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young-Kug Kim

Professor

Asan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

The difference of arterial oxygen partial pressure (PaO2) between group P and group Z

Time Frame: 1 hour after LMA insertion

The difference of arterial oxygen partial pressure (PaO2) between group P and group Z 1 hour after LMA insertion by arterial blood gas analysis

Secondary Outcomes

  • Postoperative pulmonary complications(Up to seven days)
  • Incidence of significant leak of LMA(At 5, 30, 60 mins after LMA insertion)
  • Complications associated with LMA(1 hour after end of surgery)

Study Sites (1)

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