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NCT Number: NCT03390127

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP

Other

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

Other names: Application of PEEP 7 cmH2O

Primary outcomes

  1. 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

  1. Postoperative pulmonary complications

    Time frame: Up to seven days

    Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure

  2. Complications associated with LMA

    Time frame: 1 hour after end of surgery

    Complications associated with LMA include oropharyngolaryngeal injury and sore throat.

  3. Incidence of significant leak of LMA

    Time frame: At 5, 30, 60 mins after LMA insertion

    Significant leak of LMA means that leak friction is more than 0.2.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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