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

April 5, 2018 updated by: Young-Kug Kim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group P
After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation.
Other: PEEP
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
No Intervention: Group Z
After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour after LMA insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: Up to seven days
Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure
Up to seven days
Complications associated with LMA
Time Frame: 1 hour after end of surgery
Complications associated with LMA include oropharyngolaryngeal injury and sore throat.
1 hour after end of surgery
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.
At 5, 30, 60 mins after LMA insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2018

Primary Completion (Actual)

March 14, 2018

Study Completion (Actual)

March 21, 2018

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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