Back to resultsEffect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™
Primary Purpose
Urinary Bladder Neoplasms, Prostatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEEP
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Bladder Neoplasms focused on measuring elderly, lithotomy position, PEEP, laryngeal mask airway
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
Sites / Locations
- Asan medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group P
Group Z
Arm Description
After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation.
After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postoperative pulmonary complications
Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure
Complications associated with LMA
Complications associated with LMA include oropharyngolaryngeal injury and sore throat.
Incidence of significant leak of LMA
Significant leak of LMA means that leak friction is more than 0.2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03390127
Brief Title
Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Prostatic Neoplasms
Keywords
elderly, lithotomy position, PEEP, laryngeal mask airway
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group P
Arm Type
Experimental
Arm Description
After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation.
Arm Title
Group Z
Arm Type
No Intervention
Arm Description
After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation.
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
Application of PEEP 7 cmH2O
Intervention Description
After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.
Primary Outcome Measure Information:
Title
The difference of arterial oxygen partial pressure (PaO2) between group P and group Z
Description
The difference of arterial oxygen partial pressure (PaO2) between group P and group Z 1 hour after LMA insertion by arterial blood gas analysis
Time Frame
1 hour after LMA insertion
Secondary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure
Time Frame
Up to seven days
Title
Complications associated with LMA
Description
Complications associated with LMA include oropharyngolaryngeal injury and sore throat.
Time Frame
1 hour after end of surgery
Title
Incidence of significant leak of LMA
Description
Significant leak of LMA means that leak friction is more than 0.2.
Time Frame
At 5, 30, 60 mins after LMA insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™
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