Urinary Bladder NeoplasmsNCT03390127
Effect of PEEP on Arterial Oxygen Partial Pressure in Elderly Patients With Lithotomy Position Using LMA Supreme™
A study testing PEEP in people with Urinary Bladder Neoplasms and Prostatic Neoplasms, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Urinary Bladder Neoplasms, Prostatic Neoplasms
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2018to 21 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Urinary Bladder Neoplasms, Prostatic Neoplasms
- Being tested
- PEEP
- Keywords
- elderly, lithotomy position, PEEP, laryngeal mask airway
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
Also called Application of PEEP 7 cmH2O
After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | After LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation. Receives: Other: PEEP |
| Group Z | No intervention | After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour after LMA insertion
Secondary outcomes (3)
Postoperative pulmonary complications
Postoperative pulmonary complications include atelectasis, pneumothorax, bronchospasm, pneumonia, pulmonary edema, pleural effusion, respiratory failure
Measured: Up to seven days
Complications associated with LMA
Complications associated with LMA include oropharyngolaryngeal injury and sore throat.
Measured: 1 hour after end of surgery
Incidence of significant leak of LMA
Significant leak of LMA means that leak friction is more than 0.2.
Measured: At 5, 30, 60 mins after LMA insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start5 Jan 2018
- Primary completion14 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390127
- Sponsor's protocol ID
- 2017-1397
- Status last verified
- Apr 2018
- First submitted
- 26 Dec 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03390127
- Acronym / sponsor ID
- 2017-1397
- Conditions
- Urinary Bladder Neoplasms, Prostatic Neoplasms
- Keywords
- elderly, lithotomy position, PEEP, laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Other: PEEPAfter LMA Supreme™ insertion, PEEP of 7 cmH2O would apply during general anesthesia with mechanical ventilation. |
| Group Z | No intervention | –After LMA Supreme™ insertion, PEEP would not apply during general anesthesia with mechanical ventilation. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEPAlso: Application of PEEP 7 cmH2OAfter LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation. | Other | Group P |
Primary outcome
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
3 secondary outcomes
Postoperative pulmonary complications
Time frame: Up to seven days
Complications associated with LMA
Time frame: 1 hour after end of surgery
Incidence of significant leak of LMA
Time frame: At 5, 30, 60 mins after LMA insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Urinary Bladder Neoplasms and Prostatic Neoplasms, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of arterial oxygen partial pressure (PaO2) between group P and group Z (time frame: 1 hour after LMA insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.