Robot Assisted Laparoscopic ProstatectomyNCT03202953
Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
A study testing ventilation strategy 1 and ventilation strategy 2 in people with Robot Assisted Laparoscopic Prostatectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Robot Assisted Laparoscopic Prostatectomy
- What is being tested?
- ventilation strategy 1 and ventilation strategy 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Jul 2017to 24 Jan 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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (20-80 years old)
- patients undergoing robot assisted laparoscopic prostatectomy
Who cannot join
- history of COPD
- decreased heart function (EF <50%)
- BMI>30
- patients who cannot read the consent form (e.g., blind, foreigner)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
The purpose of this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy
- Being tested
- ventilation strategy 1, ventilation strategy 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation strategy 1Procedure or surgery
In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV.
- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.
ventilation strategy 2Procedure or surgery
In group A, after trendelenburg position, patients will be applied autoflow VCV.
- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used.
| Study group | Role | What they receive |
|---|---|---|
| 1:1 I:E ratio VCV (Group I) | Experimental | volume controlled ventilation with 1:1 inspiratory to expiratory ratio After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. Receives: Procedure: ventilation strategy 1 |
| autoflow VCV (Group A) | Active comparator | autoflow volume-controlled ventilation After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. Receives: Procedure: ventilation strategy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
PaO2 analyzed by arterial blood gas analysis
Measured: 30 minutes after trendelenburg position
Secondary outcomes (5)
PaO2
Measured: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
End tidal CO2
Measured: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
peak airway pressure
Measured: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
blood pressure
Measured: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Arterial blood gas analysis
pH, SaO2, Base excess
Measured: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start4 Jul 2017
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robot Assisted Laparoscopic ProstatectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. 1:1 I:E ratio VCV group 2. autoflow VCV group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202953
- Sponsor's protocol ID
- 4-2017-0400
- Status last verified
- May 2018
- First submitted
- 26 Jun 2017
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume Controlled Ventilation With 1:1 Inspiratory to Expiratory Ratio and Autoflow-volume Controlled Ventilation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
- ClinicalTrials.gov ID
- NCT03202953
- Acronym / sponsor ID
- 4-2017-0400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 29 Jun 2017 (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 this study is to compare the 1: 1 I: E ratio VCV and the autoflow VCV in patients undergoing robot assisted laparoscopic prostatectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. 1:1 I:E ratio VCV group 2. autoflow VCV group
| Arm | Type | Receives |
|---|---|---|
| 1:1 I:E ratio VCV (Group I) | Experimental | Procedure: ventilation strategy 1volume controlled ventilation with 1:1 inspiratory to expiratory ratio After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. |
| autoflow VCV (Group A) | Active comparator | Procedure: ventilation strategy 2autoflow volume-controlled ventilation After trendelenburg position, Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult (20-80 years old)
- patients undergoing robot assisted laparoscopic prostatectomy
Key exclusion criteria (4 listed)
- history of COPD
- decreased heart function (EF <50%)
- BMI>30
- patients who cannot read the consent form (e.g., blind, foreigner)
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 |
|---|---|---|
| ventilation strategy 1In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV. * Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. | Procedure or surgery | 1:1 I:E ratio VCV (Group I) |
| ventilation strategy 2In group A, after trendelenburg position, patients will be applied autoflow VCV. - Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used. | Procedure or surgery | autoflow VCV (Group A) |
Primary outcome
PaO2
Time frame: 30 minutes after trendelenburg position
PaO2 analyzed by arterial blood gas analysis
5 secondary outcomes
PaO2
Time frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
End tidal CO2
Time frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
peak airway pressure
Time frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
blood pressure
Time frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
Arterial blood gas analysis
Time frame: 10 minutes after induction (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3), 10 minutes after supine position (T4)
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 May 2018.
- Individual participant dataSharing planned: No
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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.
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 ventilation strategy 1 and ventilation strategy 2 in people with Robot Assisted Laparoscopic Prostatectomy, run by Yonsei University 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 2 inclusion and 4 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 May 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?
PaO2 (time frame: 30 minutes after trendelenburg position). 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 May 2018.