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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390127
• Other study ID #: 2017-1397
• Status: Completed
• Phase: N/A
• First received: December 26, 2017
• Last updated: April 5, 2018
• Start date: January 5, 2018
• Est. completion date: March 21, 2018

Study information

• Verified date: April 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 21, 2018
• Est. primary completion date: March 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of arterial oxygen partial pressure (PaO2) between group P and group Z	The difference of arterial oxygen partial pressure (PaO2) between group P and group Z 1 hour after LMA insertion by arterial blood gas analysis	1 hour after LMA insertion
Secondary	Postoperative pulmonary complications	Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure	Up to seven days
Secondary	Complications associated with LMA	Complications associated with LMA include oropharyngolaryngeal injury and sore throat.	1 hour after end of surgery
Secondary	Incidence of significant leak of LMA	Significant leak of LMA means that leak friction is more than 0.2.	At 5, 30, 60 mins after LMA insertion