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

Not Applicable

Completed

• Conditions: Urinary Bladder Neoplasms; Prostatic Neoplasms
• Interventions: Other: PEEP

• Registration Number: NCT03390127
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-04
• Study Start: 2018-01-05
• Primary Completion: 2018-03-14
• Study Completion: 2018-03-21
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The difference of arterial oxygen partial pressure (PaO2) between group P and group Z	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 Outcome Measures

Name	Time	Method
Postoperative pulmonary complications	Up to seven days	Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure
Incidence of significant leak of LMA	At 5, 30, 60 mins after LMA insertion	Significant leak of LMA means that leak friction is more than 0.2.
Complications associated with LMA	1 hour after end of surgery	Complications associated with LMA include oropharyngolaryngeal injury and sore throat.

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of