Effects of Recruitment Maneuver During Intraoperative and Postoperative PeriodNCT02013011
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
A study testing recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only in people with Effects of Recruitment Maneuver During Intraoperative and Postoperative Period, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Effects of Recruitment Maneuver During Intraoperative and Postoperative Period
- What is being tested?
- recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Dec 2014
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60~80 yr
- American Society of Anesthesiologists physical status 1 or 2
- scheduled for elective robotic assisted radical prostatectomy
Who cannot join
- heavy smoker
- severe respiratory or cardiac disease
- hepatic or renal function impairment
- neurologic disease
- BMI > 31kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.
- Being tested
- recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP onlyProcedure or surgery
application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group
| Study group | Role | What they receive |
|---|---|---|
| recruitment maneuver and PEEP | Active comparator | apply recruitment maneuver and positive end expiratory pressure (PEEP) 5 centimeter of water (cmH2O) after induction of anesthesia Receives: Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only |
| PEEP | Active comparator | apply positive end expiratory pressure (PEEP) 5 cmH2O after induction of anesthesia Receives: Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of perioperative complication
check the rate of perioperative complication( desaturation during operation and postoperative atelectasis in each groups
Measured: perioperative period
Secondary outcomes (1)
respiratory index
static \& dynamic compliance, results of arterial blood gas analysis
Measured: intraoperative respiratory index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Recruitment Maneuver During Intraoperative and Postoperative PeriodStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013011
- Sponsor's protocol ID
- B-1306/206-004
- Status last verified
- Jul 2014
- First submitted
- 11 Dec 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02013011
- Acronym / sponsor ID
- B-1306/206-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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.
This study is to evaluate effects of recruitment maneuver in patients undergoing robotic assisted radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recruitment maneuver and PEEP | Active comparator | Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP onlyapply recruitment maneuver and positive end expiratory pressure (PEEP) 5 centimeter of water (cmH2O) after induction of anesthesia |
| PEEP | Active comparator | Procedure: recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP onlyapply positive end expiratory pressure (PEEP) 5 cmH2O after induction of anesthesia |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60~80 yr
- American Society of Anesthesiologists physical status 1 or 2
- scheduled for elective robotic assisted radical prostatectomy
Key exclusion criteria (5 listed)
- heavy smoker
- severe respiratory or cardiac disease
- hepatic or renal function impairment
- neurologic disease
- BMI > 31kg/m2
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 |
|---|---|---|
| recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP onlyapplication of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group | Procedure or surgery | PEEP, recruitment maneuver and PEEP |
Primary outcome
rate of perioperative complication
Time frame: perioperative period
check the rate of perioperative complication( desaturation during operation and postoperative atelectasis in each groups
1 secondary outcome
respiratory index
Time frame: intraoperative respiratory index
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 18 Apr 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only in people with Effects of Recruitment Maneuver During Intraoperative and Postoperative Period, run by Seoul National University Hospital 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 3 inclusion and 5 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 18 Apr 2016. 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?
rate of perioperative complication (time frame: perioperative period). 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 18 Apr 2016.